68 Process Validation jobs in Ireland

Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As a Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the c GMP manufacture of biological bulk drug substance (BDS) at Wu Xi Biologics facility in Louth. The Cleaning Validation Engineer will validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. The position is accountable for timely completion of cleaning validation related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility. Essential Duties and Responsibilities Develop and implement cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems. Ensure following Eudra Lex GMP guidelines. Lead cleaning validation projects for media, buffer, upstream and downstream equipment trains. Collaborate closely with colleagues within the Process Engineering and Validation team and cross functional departments (QA, Manufacturing, Automation and QC). Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required. Own the PEV procedures and plans associated with cleaning validation activities. Prioritise cleaning validation activities in line with the project schedule. Implement product change over assessments. Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required). Identify and implement improvements where feasible to cleaning processes. Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale. Temporary shift working may be required during periods of engineering batch and validation batch execution. Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations. Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections. Will be flexible to take on additional tasks and responsibilities at the discretion of the Process Engineering and Cleaning Validation Lead. Will function as a role model for the Engineering function and the wider organisation in adherence to the Wu Xi corporate core values and PROUD culture. Technical Competencies Experience of cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility. Experience in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing. Experience A minimum of 8 years cleaning validation experience leading cleaning validation programmes in multiproduct facilities. Knowledge and experience with facility start-up projects (brown field or green field) is advantageous. Experience operating in a fully automated Delta V facility. Excellent communication skills including computer literacy and ability to work independently and in a team. Thorough knowledge of current Good Manufacturing Practices (c GMP). Familiarity with Chromatography and Ultra filtration production operations is desired. Qualifications BEng or BSc in Chemical / Process engineering or relevant science discipline is required. A postgraduate qualification in an engineering or scientific discipline would be advantageous. A qualification in project management would be advantageous. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Good people skills coupled with demonstrated ability to collaborate effectively across functions and sites. Ability to present and successfully defend technical and scientific approaches in both written and verbal form. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities. Results oriented, with the ability to manage multiple priorities in a short period of time. Engage cross functionally in conjunction with a site-based team. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at Wu Xi Biologics is an equal opportunities employer. Skills: Cleaning Validation c GMP Compliance CIP/COP Systems Delta V Automation Chromatography Operations Technical Documentation Facility Start-Up Projects Benefits: Bonus Educational assistance Life Assurance Pension VHI

**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Diabetes Care Kilkenny**
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
**This is how you can make a difference at Abbott:**
In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.
**You will be responsible for:**
+ Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
+ Complete impact assessments of proposed changes and/or new products and determine scope of validation work
+ Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
+ Identification of improvements to manufacturing process & software and assist with implementation of same
+ Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management
+ Provide direction and mentoring to junior engineers as required
+ Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
+ Knowledge of cGMP and industry regulations
**QUALIFICATIONS AND EXPERIENCE**
+ Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
+ Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
+ 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
+ Basic understanding of design controls, design transfer and validation lifecycle.
+ Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
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Abbott is an equal opportunities employer.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

A Validation Engineer is required by CareerWise Recruitment for our Waterford based pharmaceutical client. If you are experience in aseptic processing, lyophilisation, sterilisation and depyrogenation. This is a 12 month contract. THE ROLE: Designing, executing and reporting on PV/Process Performance Qualifications. Designing, executing and reporting on validation studies for equipment, systems and processes. Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation Maintaining validation documentation through the validation lifecycle Participation in external regulatory inspections and supporting Support Site Change Control process Capable of troubleshooting validation issues associated with projects, process development etc. Maintaining validation documentation through the validation lifecycle REQUIREMENTS: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec Previous validation/product development experience would be highly advantageous for the role. Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations. Knowledge of requirements for of GAMP, ISPE Baseline guides. Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines. Full understanding of relevant quality and compliance regulations Able to execute projects to plan. Good knowledge of quality management systems. Good communication skills at organisation, team and individual levels. Ability to use MS Project and SPC packages an advantage Please call Louise Mulligan 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. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Validation Engineer aseptic processing lyophilisation

Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are looking for an experienced Validation Engineer to work on a Client site in Cork. The Validation Engineer will be responsible for the equipment Validation of a technology transfer of existing processes from another site. Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization). Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply. Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements. Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria. Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards. Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test. Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution. Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems. Qualifications B.S. in Engineering and 3-7 years of experience or related equivalent work experience Must have experience with cGMPs and Good Engineering Practices. Experience in executing multiple projects and participating on cross-functional project teams Knowledge of automation validation preferred Knowledge of Quality control equipment qualification a plus

Validation Engineer The successful Validation Engineer will report to the Project Validation Lead and assist the team for project qualification. A Degree qualified Engineer with B.S. in Engineering and 3+ years of experience or related equivalent work experience Must have experience with cGMPs and Good Engineering Practices. Experience in executing multiple projects and participating on cross-functional project teams. Duties and Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization). Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply. Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements. Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria. Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards. Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test. Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution. Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems. Arcadis | DPS Group is a leading Project Management and Engineering Company delivering Full-Service Engineering with a client first mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time. Arcadis | DPS Group is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.

Purpose In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. The following activities will be included as part of your role Responsibilities Designing, executing and reporting on PV/Process Performance Qualifications. Designing, executing and reporting on validation studies for equipment, systems and processes. Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.) Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times Maintaining validation documentation through the validation lifecycle Participation in external regulatory inspections Support Site Change Control processes Qualifications Education: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec) 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector Capable of troubleshooting validation issues associated with projects, process development etc. Competent technical knowledge of pharmaceutical plants. Previous validation/product development experience would be highly advantageous for the role. Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations. Knowledge of requirements for of GAMP, ISPE Baseline guides. Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines. Skills: NPI Equipment Qualification Process Performance Qualifications PV

**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Nutrition Division Cootehill Cavan**
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name "Similac". To complement the range of "Similac" infant formulae, the facility also manufactures a range of follow-on formulae under the brand name of "Gain". The essential ingredient is liquid skim-milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, Southeast Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland's reputation as a green, clean environment, is of significant strategic importance to Abbott Nutrition.
**The Role**
As a Validation Engineer you will work within the Packing Department Projects division supporting a team of Project Engineers in the delivery of improvements to help integrate new products or processes into the existing manufacturing area, through the creation of documents and execution of validation work in compliance with current regulatory and company requirements. The successful candidate will report directly to the Packing Principal Programme Manager.
**Major Responsibilities**
- Provide direction, documentation, execution and review for project validation activities.
- Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
- Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects
- Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.
**Primary Function / Goals / Objectives**
- Responsible for supporting plant capital projects as assigned.
- Support Snr Project Engineers with the development of project documentation. - Development and execution of validation protocols (FAT, DQ, IQ, OQ PQ).
- Execution of change controls.
- Management of any project associated Quality issues and CAPA's.
- Work closely with Snr Project Engineers to ensure the work being undertaken is correctly documented in advance and the validation implications have been considered.
- Attend weekly Validation Review meetings with other engineers from around the site and the Quality/Validation Manager to ensure co-ordination of effort and minimising of unforeseen impacts.
- Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.
- Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects
- Utilise QA IT Systems (M-FILES) through which Validation Change Control is documented.
- Provide direction, documentation, execution and review for project validation activities.
- Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
- Work closely with the Validation and Manufacturing Team.
- Work closely with project equipment vendors to obtain information to successfully specify requirements for plant and facility.
- Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.
- It is a requirement to have experience and knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.
- Good Team Player
- Flexible with a can-do attitude
- Follow all Health and Safety Rules and Regulations in the plant
- Maintain plant safety at the highest level with a zero-accident target and with immediate response and thorough investigation and corrective action for all hazardous occurrences and accidents.
- It is important that GMP is a main priority in any operation carried out in this job function.
- Establish communication lines with all other departments e.g. Manufacturing, Q.A., Materials, Human Resources, Technical Operation Support and Finance.
- Plan and schedule work in accordance with plant demand and available manpower.
- Ensure compliance with Company International Global Standards, GMP & Environmental requirements.
- Responsible for promoting good employee relations.
- This job function will change where update procedures to GMP, EHS, Technical/New Equipment, Quality procedures and SOPs are made.
- Support Business Excellence initiatives in the plant.
**Education Required**
- Bachelor's Degree in Engineering or equivalent discipline.
Technical / Business Knowledge
- Minimum of 3 years relevant experience in Engineering.
- Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage).
- Good mental ability to logically follow a line of though for problem solving. Accountability / Scope
- Considerable and continual care and attention is needed to avoid substantial damage to equipment.
- Continual attention needed to ensure plant reaches its annual production plan. - Failure on the incumbent part not to exercise due care could cause repeated small losses or occasional damage.
- Environmental non-compliance will result in EPA/Legal censorship.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Overview: Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements. Key Responsibilities: Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT) and Performance Qualifications (PQ's) associated with a Syringe Filling Line. Pre-Approve and Post-Approve validation protocols. Input into site Validation Master Plans and Standard Operating Procedures (SOP's) Collate and Report on relevant validation data/metrics. Assist in exceptions and deviation resolution and root cause analysis. Reviews Validation planning documents detailing overall strategy for the project. Reviews and Approves Qualification summary reports (QSR) Generates Validation Summary reports. Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES) Education / Experience: 6+ years experience in Engineering or Validation Technical qualification at third level or equivalent in Engineering. Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects Experience of sterile / biotech equipment within the pharmaceutical industry is preferred. Knowledge of safety and GMP requirements. Demonstrated strong Communication skills Experience using Paperless Qualification Systems is preferred. Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry Skills: Factory Acceptance Testing Sterile fill finish facility Instillation Verification (IVs) Functional Testing (FTs) Validation Document Review & Approval

GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team. The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards. Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. To start the process click the Continue to Application or Login/Register to apply button below.