340 Manufacturing Qa jobs in Ireland

We're looking for a hands-on manufacturing quality engineer who thrives on solving problems - not just reporting them. This is a practical, on-the-floor role supporting the production of high performance heating systems used across Europe.

You'll work with R&D to launch new products, lead ISO audits, troubleshoot quality issues, and implement real changes on the ground. One day you're breaking down problems with suppliers; the next, you're improving processes or rolling out component changes.

Experience in manufacturing and ISO is essential. Sheet metal and electrical assembly knowledge (cables, crimping, LEDs) is a big plus. AutoCAD Inventor and Excel required.

This role suits someone who doesn't want to sit behind a desk all day—someone who owns issues, drives improvements, and follows through.

Specific Skills / Expectations for the right candidate:

Manufacturing Engineering

Work with R&D and Production to assist with New Product Introductions

Manage Engineering Change Notices

Technical Liaison with suppliers

Create Work Instructions and Procedures for Manufacturing Tasks.

Organise external Maintenance Contractors

Preventive Maintenance Schedule

Manage Bills of Material

Seek and Implement Product Cost Reduction Opportunities

Safety, carry out audits, attend meetings, close out actions.

Work toward 5S implementation.

Quality Engineering

ISO Audits

Collect Quality Data and prepare for presentation to Senior Management

Work with Customer Service to identify patterns in calls.

Update Procedures and Policies

Create and Close Out Corrective Action Reports

Manage Supplier Returns and Credits

Liaison to suppliers on Quality Issues

Host Quality Meetings.

Maintain Quality KPIs

Write Specific Quality Reports when required

Skills:

Autocad Excel ISO 9001 Iso 9000 Manufacturing Sheet Metal Electrical

Are you a Quality/Manufacturing engineer looking for a new opportunity? Don't hesitate and apply today

PROJECT DESCRIPTION
We are seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483. These roles will focus on manufacturing process validation, quality system updates, and documentation remediation. Consultants will be based onsite and work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.

The project will involve tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes. Consultants must be able to take a problem statement through to a compliant solution, collaborating cross-functionally across Quality, Manufacturing, and Regulatory teams.

PROJECT DESCRIPTION

• Partner with process owners on the floor to capture and remediate issues.
• Support process validation (IQ/OQ/PQ) and documentation updates.
• Drive CAPA/NCR closure and implement compliant solutions.
• Provide technical writing for quality and manufacturing documents.
• Collaborate cross-functionally to ensure regulatory compliance.

CONSULTANT RESPONSIBILITIES

• Engineering or Quality degree with 5-10 years' med-tech experience.
• Background in remediation, process validation, CAPA, NCRs.
• Strong technical writing and documentation skills.
• Knowledge of 21 CFR Part 820, ISO 13485.

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

Inspire and be inspired. We offer a variety of opportunities for undergraduate and post-graduate students to use your talent, skills, education and passion to help make an impact on patient's lives - all while growing your career and

earning academic credit.

Our Internship Programme gives you a real opportunity to gain practical 'hands-on' experience, training and shadow the experts of your chosen field. It also provides you with insight into what it's like to work with us.
We will place you in a six-, nine- or twelve-month Internship Programme depending on the requirements of your degree course. So, are you ready to embark on a new adventure? We can't wait to see what you're made of

Activities you will be involved in during your placement as
QA Operations Intern
include:

• Support the Qualified Person disposition process for Drug Substance/Drug Product.
• Support the QA Manufacturing Operations shift team and batch record review process.
• Conduct QA review and approval of functional area documentation.
• Support the disposition process for Working Cell Banks to ensure timely release to manufacturing operations.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Liaise with BMS Supply Chain and Quality colleagues to ensure that disposition lead times are consistently met.
• Prepare and present Quality metrics to support timely approval of batch records, closure of investigations and Drug Substance release.
• Support the site inspection readiness program for internal and external regulatory inspections.
• Support the progression of GMP documents within the Documentation Management System.
• Support the administration of Annual Product Quality Reviews.
• Authoring, review and approval of QA-related procedures.
• Identify and implement continuous improvements within the QA group to support business processes and metrics.
• Engage in Quality Culture initiatives.

Due to the nature of the role, you may work in other and/or multiple QA areas once the appropriate training has been completed.

What Qualities Are We Looking For?
We are looking for highly motivated individuals who can collaborate in teams and have the willingness to learn.

• Chemical & Pharmaceutical Sciences, Pharmacy, Biomolecular & Biomedical Science or Pharmaceutical & Biomedical Chemistry discipline of study.
• Passionate about the biopharma sector and innovation in healthcare.
• Strong communication skills.
• Ability to work as a member of a team.
• Energetic, collaborative and dedicated.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Responsibilities
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Cohesity is the leader in AI-powered data security. Over 13,600 enterprise customers, including over 85 of the Fortune 100 and nearly 70% of the Global 500, rely on Cohesity to strengthen their resilience while providing Gen AI insights into their vast amounts of data. Formed from the combination of Cohesity with Veritas' enterprise data protection business, the company's solutions secure and protect data on-premises, in the cloud, and at the edge. Backed by NVIDIA, IBM, HPE, Cisco, AWS, Google Cloud, and others, Cohesity is headquartered in Santa Clara, CA, with offices around the globe.

We've been named a Leader by multiple analyst firms and have been globally recognized for Innovation, Product Strength, and Simplicity in Design , and our culture.

Want to join the leader in AI-powered data security?
Cohesity is seeking a
Senior Manufacturing Quality Engineer
responsible for driving manufacturing quality excellence across the server/storage product portfolio. The ideal candidate will focus on developing and sustaining quality processes across the product lifecycle—from NPI to production—ensuring robust box build process controls, supplier quality, and issue resolution. This individual will work closely with hardware engineering, manufacturing, test engineering, supplier quality, and supply chain teams. This full-time position reports to the Manager of Quality Engineering within the Operations Engineering organization.

How You'll Spend Your Time Here

• Own and improve quality processes across manufacturing lines (system assembly, test, packaging, etc.)
• Lead root cause analysis and drive corrective/preventive actions (RCCA) on manufacturing quality escapes, yield issues, and process deviations.
• Monitor in-line quality metrics and yield data; identify trends and proactively drive continuous improvement.
• Support NPI builds by establishing quality inspection plans, control plans, and incoming inspection criteria.
• Collaborate with OEM/ODM/CM partners to ensure adherence to quality standards and process capability requirements.
• Lead regular quality reviews with manufacturing partners and internal stakeholders to align on metrics, priorities, and actions.
• Perform audits (internal and supplier) to assess quality system compliance and drive closure of any non-conformities.
• Partner with test and engineering teams to qualify new processes, fixtures, and equipment from a quality standpoint.
• Manage and maintain the manufacturing quality documentation (e.g., Specs., Control Plans, Quality Alerts).
• Be the first point of contact for any factory quality issues.
• Drive measurable improvements in production yields, defect rates, and manufacturing quality metrics.
• Deliver high-quality NPI launches with robust quality plans and minimal escapes.
• Be a key interface between engineering and manufacturing on quality-related topics.
• Foster a culture of continuous improvement with internal and external manufacturing teams.

WE'D LOVE TO TALK TO YOU IF YOU HAVE MANY OF THE FOLLOWING:

• Strong knowledge of PCBA and system-level manufacturing processes, quality controls, and test methodologies.
• Experience with quality engineering tools (e.g., 8D, 5Whys, Fishbone, FMEA, DMAIC, SPC analysis).
• Working knowledge of manufacturing quality standards (e.g., ISO 9001, IPC-A-610).
• Hands-on experience collaborating with contract manufacturers and suppliers, preferably in the server/storage industry.
• Excellent data analysis and reporting skills (Excel, Tableau, SQL or other BI tools).
• Exceptional problem-solving and communication skills across cross-functional teams.
• Flexibility to support builds in multiple time zones and in a fast-paced product ramp environment.
• Demonstrated ability to leverage AI tools to enhance productivity, streamline workflows, and support decision making

Data Privacy Notice For Job Candidates
For information on personal data processing, please see our Privacy Policy
.
**Equal Employment Opportunity Employer (EEOE)

Cohesity is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, national origin or nationality, ancestry, age, disability, gender identity or expression, marital status, veteran status or any other category protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at COHESITY or

for assistance.
In-Office Expectations

Cohesity employees who are within a reasonable commute (e.g. within a forty-five (45) minute average travel time) work out of our core offices 2-3 days a week of their choosing.
Interested candidates based outside of the designated areas are welcome to apply, provided they have the right to work in the job location.

QUALITY ASSURANCE SPECIALIST, API EXTERNAL MANUFACTURING required by CareerWise Recruitment for our multinational Life Sciences client at their facility in Co. Cork.initial 12 month contract on offer.

The QUALITY ASSURANCE SPECIALIST, API EXTERNAL MANUFACTURING will need to have large molecule / bio experience with a minimum of 5 years' experience required. Experience with external OR 3rd party manufacturers would be a distinct advantage.

NOTE:
No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

RESPONSIBILITIES:

• Serve as a liaison between Contract Manufacturing organizations and the client.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of APIEM Quality Plans
• Coordinate and perform QA responsibilities of API shipments.
• Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
• Participate on the Technical Review Board
• Evaluate and disposition API batches, if required.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
• Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

REQUIREMENTS:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
• Experience in quality support for Quality Control activities
• Thorough technical understanding of quality systems and regulatory requirements.
• Knowledge of pharmaceutical manufacturing operations.

Please call Conor Twomey today for further information on or email:

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

Bristol Myers Squibb Ireland
Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

For more information about Bristol Myers Squibb, visit us at

The Role
BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QA Manufacturing Operations for Sterile Drug Product.

Reporting to the Manager, QA Manufacturing Operations for Sterile Drug Product, the Senior Specialist(s) will support the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline. This shall be achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing quality assurance oversight for all phases of the project.

In addition, this role will support readying the facility for manufacturing operations on a 24/5 basis, supporting the Tech Transfer program for new products introduced into the facility.

Post start-up the successful candidate will support the execution and maintenance of the QA activities related to the commercial sterile drug product manufacture and release activities on shift in Cruiserath. This is a 24/5 shift role.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
• Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.

• Support CQV / Tech Transfer / Operational Readiness activities including but not limited to:

• New Product Introduction

• SOP Development and Implementation
• Training Material development
• MES / MBR Design

• CQV support as required

• Develop and execute training programs in support of multiproduct manufacturing.

• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities During Commercial Operations

• QA support of manufacturing operations (commercial operations and new product introductions)
• Batch record review and on the-floor support of manufacturing activities
• Provision of quality oversight for the inspection program
• QA Operations review of events and investigations
• Authoring, review, and approval of QA-related procedures
• Review and approval of functional area documentation
• Support the Disposition process for commercial and clinical drug product.
• Participation in GMP reviews for new facility construction and new equipment support systems
• QA support for implementation of Manufacturing Execution System (MES) and development of batch records
• Change control assessment and CAPA evaluation/CAPA close-out.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support external and internal audits.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Designee for Manager, Sterile Drug Product, QA Manufacturing Operations, when required.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications, Knowledge and Skills Required:

• BSc in Science or related discipline with a minimum of years' QA Operations or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task
• Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Responsibilities
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more .

Bristol Myers Squibb Ireland
Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

For more information about Bristol Myers Squibb, visit us at

The Role
BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QA Manufacturing Operations for Sterile Drug Product.

Reporting to the Manager, QA Manufacturing Operations for Sterile Drug Product, the Senior Specialist(s) will support the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline. This shall be achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing quality assurance oversight for all phases of the project.

In addition, this role will support readying the facility for manufacturing operations on a 24/5 basis, supporting the Tech Transfer program for new products introduced into the facility.

Post start-up the successful candidate will support the execution and maintenance of the QA activities related to the commercial sterile drug product manufacture and release activities on shift in Cruiserath. This is a 24/5 shift role.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
• Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.

• Support CQV / Tech Transfer / Operational Readiness activities including but not limited to

• New Product Introduction

• SOP Development and Implementation
• Training Material development
• MES / MBR Design

• CQV support as required

• Develop and execute training programs in support of multiproduct manufacturing.

• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities During Commercial Operations

• QA support of manufacturing operations (commercial operations and new product introductions)
• Batch record review and on the-floor support of manufacturing activities
• Provision of quality oversight for the inspection program
• QA Operations review of events and investigations
• Authoring, review, and approval of QA-related procedures
• Review and approval of functional area documentation
• Support the Disposition process for commercial and clinical drug product.
• Participation in GMP reviews for new facility construction and new equipment support systems
• QA support for implementation of Manufacturing Execution System (MES) and development of batch records
• Change control assessment and CAPA evaluation/CAPA close-out.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support external and internal audits.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Designee for Manager, Sterile Drug Product, QA Manufacturing Operations, when required.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications, Knowledge and Skills Required

• BSc in Science or related discipline with a minimum of years' QA Operations or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task
• Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.