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JOB SUMMARY
Project Manager II will lead and support assigned projects, programs and initiatives of medium to high complexity applying project management expertise to support the company and group’s strategy. Manage assigned projects through the various stages of the project lifecycle, from concept to implementation. This includes developing SOW, business proposals, functional requirements, project plan w/milestones, financials, and implementation plan. Provide management and guidance toward successful collaboration with multi-functional groups and direct project team responsible for implementation of Jabil’s strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
·    Define concise goals and objectives within a project framework
·    Ensure all project requirements and/or objectives are correctly gathered, understood and properly translated for execution.
·    Define and recognize project Key Performance Indicators and manage the work within scope, quality, time and cost constraints
·    Conduct project risk reviews and appropriate mitigation
·    Facilitate communication as appropriate to all involved and "manage" the stakeholders. This includes escalate issues to the next level of management
·    Forecast project budget and staffing needs for current and future site needs
·    Accountable for overall project success - including cost, schedule, quality, and scope management.
·    Manage the overall budget of assigned projects.
·    Accountable for customer satisfaction / relationship both internal and external as deemed relative or necessary to project success.
·    Ability to form and lead strong multi-functional teams to achieve company and/or customer objectives.
·    Understand and exceed customer (internal or external) needs and expectations.
·    Identify creative ways to implement corrective actions in cost effective manner.
·    Utilize tools to track changes and identify cost impact for review with senior management.
·    Provide feedback to project team and leaders on concerns with cost.
·    Prepare timely forecasts for projects.
·    Compare forward forecast results to historical actual results for trend assessment and analysis.
·    Forecast quarterly and annual projects where applicable
·    Drive the wider team to continuously improve in key operational metrics and the achievement of the project & organizational goals.
·    Develops and owns project plan, establishing a road map with clear dates and clear deliverables.
·    Provide regular project updates to project team, relevant departments, stakeholders, project champions and senior leadership as needed.
·    Works with stakeholders to define project road maps and deliverables.
·    Clarifies and communicates project objectives and success criteria.
·    Establish and maintain communications with both customer personnel and senior management as needed.
·    Ensure all sensitive and confidential information is handled appropriately.
·    Facilitate communication and education for all interested parties as deemed necessary  
·    Responsible for managing cross-divisional / cross-functional / cross-cultural teams.
·    Builds and structures integrated teams to ensure maximum performance; provides direction and motivation.
·    Mentors and coaches project team members. Gives and receives both written and verbal feedback.
·    Identify and prepare proposals that close gaps and mitigate risk.
·    Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
·    Comply and follow all procedures within the company security policy.
·    May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
·    Experience managing multiple projects simultaneously.
·    Ability to form and lead strong multi-functional teams to achieve company and customer (internal or external) objectives.
·    Organize verbal and written ideas clearly and use an appropriate business style.
·    Ability to effectively present information to management and/or customer personnel.
·    Ability to respond in a timely fashion to common inquiries or complaints.
·    Define, develop and implement strategies contribute to the overall company and group strategic direction.
·    Demonstrate high performance orientation, detail orientation, market knowledge and sound judgment
·    Demonstrate ability to build and leverage partnerships, implement change and manage projects.
·    Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
·    Advanced PC skills, including training and knowledge of Jabil’s software packages in an integrated system such as SAP
EDUCATION & EXPERIENCE REQUIREMENTS
·    Bachelor’s degree in business management or equivalent required.
·    Minimum of 3-5 years prior experience in project management in an applicable discipline.
·    Previous experience in electronic manufacturing services a plus.
·    PMP Certification preferred.
·    Or an equivalent combination of education, experience and / or training.

1. JOB PURPOSE

Responsible for maintaining quality control processes, analyzing the results, and giving feedback and guidance to the product development and production team. In addition to overseeing stringent quality control measures, the QC Manager will also act as an integral part of the purchasing team, ensuring that purchased materials align with approved supplier lists and quality criteria while maintaining the highest standards of product quality and reliability.

1. DUTIES AND RESPONSIBILITIES

2. Liaises with Director of Operations, Head of Quality and Regulatory Affairs, Production Manager,

Project Managers, Process Scientist and Quality Assurance.

• Responsible for ensuring raw materials, intermediates, and manufactured products meet standard standards of quality, reliability, and performance.
• Ensure proper maintenance of detailed records encompassing quality tests, procedures, and established standards, facilitating a comprehensive repository that guarantees traceability and compliance within the quality control framework.
• Establish procedures and processes for sampling, recording, and reporting of quality data.
• Request quotes from suppliers for product specific materials or services.
• Carry out research to identify ways to reduce waste and maximize resources.
• Ensures that all production materials are purchased from suppliers that are listed on the Approved

Supplier List.

• Ensure manufacturing processes are in compliance with both national and international standards of production.
• Oversee and execute comprehensive quality control protocols to guarantee adherence to established standards and procedures within the organization.
• Provide strategic recommendations to company management aimed at enhancing and optimizing existing quality control processes for heightened efficiency and superior output quality.
• Supervise QC technicians to ensure they perform their duties in line with established quality

procedures.

• oversee and analyze the product development processes to promptly identify and address any

deviations or variances from established quality policies and standards.

• Approve compliant products and reject defective ones.
• Compile and present reports detailing quality control activities and findings to upper management

to provide transparent updates on the organization's adherence to quality standards and initiatives.

• Maintain proper records of quality test, procedures and standards.
• Develops and implements an electronic Quality Management System in compliance with

ISO13485, IVDR 2017/746 and FDA 21CFR820.

• Act as a Functional Manager.

• Other duties as defined by your manager a from time to time.

• QUALIFICATIONS

• A bachelor's degree in a related field; a graduate degree is recommended for advancement.

• 3 years experience within a similar role within a regulated industry
• Good communication skills for effective liaison and teamwork.
• Problem-solving skills, analytical skills, and attention to detail.
• Excellent organisational skills and the ability to work on several tasks or projects concurrently.
• Commercial acumen and an awareness of the business value of work undertaken.
• Presentation skills - for presenting ideas and findings to colleagues and customers.
• The ability to work well independently, with minimum supervision.

• Drive, enthusiasm, and self-motivation.

• WORKING CONDITIONS

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually moderate.

• PHYSICAL REQUIREMENTS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required

by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their manager.

Job Type: Full-time

Pay: €55,000.00-€60,000.00 per year

Benefits:

• Bike to work scheme
• Company pension
• Employee assistance program
• On-site parking

Work authorisation:

• Ireland (required)

Work Location: In person

This job operates on a 16/5 cycle shift pattern. This job specification outlines the general responsibilities associated with the role of Manager QC Microbiology on the Amgen Manufacturing site. This role will be responsible for managing the QC Microbiology team and owning, facilitating, and undertaking activities pertaining to Microbiology within QC and Manufacturing. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QC Microbiology duties and testing, including release of commercial and global release testing. The role also represents the QC unit by liaising with internal and external stake holders.

The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. This role will be responsible for oversight of some analytical in-process methods and may require shift work depending on company needs.

Key Responsibilities:

• Supervision/Management of QC Microbiology team.
• Ensure the QC Microbiology area is operated in a safe manner.
• Overall responsibility for QC In process, Environmental Monitoring, Release and Stability testing and the associated test and laboratory documentation.
• Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP Compliance with Standard Operating Procedures and Registered specifications.
• Provide an effective and efficient QC service to operations by supervising, developing and coaching the QC team.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Deviation procedures.
• Issue trend reports on investigations, non-conformances and Environmental Monitoring and identify laboratory practices and procedures for further development/improvement.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and quality goals.

Primary knowledge, skills, competencies and relevant experience Knowledge:

Broad technical knowledge within Microbiology and expanding knowledge of related disciplinary areas Recognizes and understands the cross-dependencies of the role and understands the impacts on the organization Enhances own knowledge through understanding business trends and objectives Knowledge of industry and business principles Understands the core business process and purpose of the functional area in Amgen's commercialization process Developing own project management techniques

Problem Solving:

Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information Creates new procedures and processes to drive desired results Handles diverse scope of issues that require evaluation of a variety of factors including current business trends

Autonomy:

Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role Experience leading cross-functional teams is desirable Work is guided by operational and project objectives Manages multiple assignments and processes Independently determines approach to project May be responsible for specific programs and/or projects Independently develops solutions that are thorough, practical, and consistent with functional objectives

Contribution:

Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean Provides training and guidance to others Extends capabilities by working closely with senior staff/experts within and outside the internal organization

Skills:

Lead with initiatives to identify and drive improvements Communication skills (verbal and written) at all levels Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) Presentation skills Escalate issues professionally and in a timely basis and know when to escalate Decision Making skills – will be require to make decisions independently Teamwork, Coaching and motivating others Negotiation and Influence skills, Planning and organisation skills Investigation skills Demonstrated ability to interact with regulatory agencies Experience working with interdepartmental and cross functional teams and influencing decisions

Relevant experience:

Bachelor's degree in a Science related field is required. 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with 2 – 3 years of specific Microbiology management experience desirable. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Some analytical experience for oversight of analytical in-process methods would be an advantage. Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Proven experience of leading teams.

Role description

Job Description Business Analyst Manufacturing Supply Chain

Location Ireland Facility Athenry

Department Manufacturing Supply Chain Operations

Client empowers people with diabetes through world leading continuous glucose monitoring CGM technology as we expand operations in Ireland our focus is on building advanced manufacturing and supply chain capabilities to deliver products at scale

We are seeking Business Analysts to partner with operations supply chain and technology teams to analyze business needs define requirements and enable data driven decisions that enhance efficiency scalability and compliance

As a Business Analyst

• Partner with stakeholders manufacturing supply chain procurement quality finance IT to gather document and translate requirements into functional specifications

• Break down business requirements into user stories and epics in JIRA ensuring traceability to business outcomes

• Support commercial readiness activities for the Athenry facility ensuring new processes systems and equipment meet operational needs

• Analyze current processes and systems to identify gaps inefficiencies and opportunities for improvement

• Collaborate with Project Managers Engineering and IT to ensure requirements align to program objectives and are delivered effectively

• Develop process flows acceptance criteria and business cases to support decisionmaking and solution design

• Contribute to the implementation and enhancement of ERP MES WMS and other operations systems

• Use JIRA dashboards to track progress dependencies and sprint deliverables across crossfunctional teams

• Support change management and training activities ensuring smooth adoption of new processes and tools

• Provide data insights and performance metrics KPIs dashboards for continuous improvement

• Ensure all business processes and documentation comply with regulatory standards FDA ISO EU MDR GMP

Qualifications

• Bachelors degree in Engineering Supply Chain Business DataIT or related field

• 10 years of experience as a Business Analyst manufacturing supply chain medical devices or pharma strongly preferred

• Proven ability to analyze complex business processes and translate them into clear system and process requirements

• Handson experience writing user stories defining epics and managing backlogs in JIRA or similar Agile tools

• Strong working knowledge of ERP SAPOracle MES WMS and data analytics tools Power BI Tableau Excel

• Familiarity with automation manufacturing operations and supply chain planning

• Excellent documentation facilitation and stakeholder management skills

• Experience in regulated environments and knowledge of FDA ISO13485 EU MDR requirements

• Exposure to Agile Lean or Six Sigma methodologies is a plus

• Ability to manage multiple priorities in a fastpaced matrixed organization

Skills

Mandatory Skills : Oracle SaaS SCM,Oracle SaaS Order Management Cloud

About LTIMindtree

LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700 clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by 83,000+ talented and entrepreneurial professionals across more than 40 countries, LTIMindtree — a Larsen & Toubro Group company — solves the most complex business challenges and delivers transformation at scale. For more information, please visit