291 Process Validation jobs in Ireland

Job description:

As a Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi 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 EudraLex 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 WuXi 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 (cGMP).
• 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 - don't 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

WuXi Biologics is an equal opportunities employer.

Validation Engineer

Location: Cork

Duration: 12 Months

Hours: 39

The Validation Engineer will be responsible for the following.

• Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP).
• Primary activities are in CPV, Process Validation Support, Supplier Qualification, Cleaning operations and cleaning validation, Continuous Improvement projects.
• Leading and/or providing technical guidance for process improvement projects and investigations.
• Secondary activities include, but are not limited to authoring protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).

Roles and Responsibilities

• Conduct MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
• Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Representing the JSI MSAT site team on platform technical teams.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions/events/deviations during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / project schedules.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of a MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.

How to Succeed

• A minimum of a Degree in Engineering, Science, Pharmacy or related scientific field is required.
• At least 3-5 yrs experience in the Small Molecule manufacturing industry or equivalent.
• Focus on patients and customers at all times.

Desirable:

• Experience in Cleaning Validation, Process Validation, Supporting process improvement projects, Supporting New product Introduction.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
• Ability to lead multi-functional team and to manage complexity and change.
• Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 months.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK:

Janssen Ireland:

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid.
PAYE, LTD & Umbrella
options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".

Senior CQV Engineer | 12-Month Contract | Biopharmaceutical Expansion Project | Client-Side | Dublin

A leading Dublin-based biopharmaceutical company are looking to onboard a Senior CQV Engineer.

Role Overview:
You will develop the CQV documentation package and oversee the installation, commissioning, and qualification of clean utilities for a large greenfield project. Your technical expertise will ensure systems, equipment, and processes meet agreed specifications.

Key Responsibilities:

• Commission and qualify Clean Utility Systems and execute qualification documentation.
• Generate all C&Q test documents (CQV Plan, Set to Works, FAT, SAT, IV, FT, CQV Summary Report).
• Provide technical assistance during investigations and system design.
• Coordinate and supervise all CQV activities on assigned systems.
• Maintain the CQV schedule.
• Manage daily CQV coordination meetings.
• Track and report CQV status and risks/issues.
• Ensure the safe and coordinated start-up of equipment/utilities.
• Assist in developing User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Education/Experience:

• 6+ years of experience in Engineering
• Technical qualification at the third level or equivalent in Engineering.
• Extensive knowledge and experience within Commissioning and Qualification for Pharmaceutical/Biotechnology projects preferred.

Note:
This is a contract position, and we cannot offer sponsorship. Please apply only if you have the right to work in Ireland.

To learn more about the role, please apply or send your CV and details to or call

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

The Validation Engineer will write, review and execute Validation Plans ,Protocols and Reports for Secondary Packaging Projects and Revalidations ensuring compliance to all relevant global and local quality and validation procedures /standard.

Initial requirements to focus on the areas of Packaging Equipment Qualification and Temperature Mapping with Utilities, Cleaning Revalidation to follow.

Represent Validation at technical forum include external and internal audits.

What you will be doing?:

• Write, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
• Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
• Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
• Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
• Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, and Maintenance ) to execute qualification and validation efforts in support of site projects.
• Completion of risk assessments, closure of corrective and preventive actions (CAPA's)
• Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.
• Performs other validation associated activities as defined by Manager or Director.

KEY COMPETENCIES

Packaging Equipment Qualification

Temperature Mapping

Computer System Validation

Clean Utilities

Cleaning Validation, preferable

Commissioning and Qualification

Documentation (Writing SOPs, Protocols, Reports)

Auditing

Strong communication / presentation skills during internal/external audits.

PERSON SPECIFICATION:

• Project Management Experience
• Hands-on knowledge of execution of Validation
• Experience in a Quality or Validation Role within Pharma sector
• Experience with Software validation for manufacturing
• Excellent Technical Writing and analytical skills.
• Familiarity with cGMPs and industry and federal guidelines required.
• Experience with Word, Excel and Access computer applications.
• Strong interpersonal skills for interactions with other departments.
• Degree in Science/Engineering and/or Min 4 years Validation experience
• Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
• Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
• Familiarity with ISO Cleanrooms and Associated Environments)
• Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
• Experience within aseptic manufacturing environment

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

Learn more about Grifols

Validation Engineer - Ireland, Dublin - 12 Months Initial Contract
Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of a Validation Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Responsibilities Include

• Support project team across new filling line introduction.
• Assists with Validation Plan development
• Write, review and execute full validation lifecycle documentation including FAT's, SAT's, IOPQ's.
• Performs other validation associated activities as defined by Manager

Requirements:

• Experience within a similar role
• GMP Capital project experience
• Full Validation Lifecycle management experience
• SME in Aseptic Filling Line Validation
• Strong communication and teamwork skills

If this role is of interest, please apply now

QA Validation Engineer

We are seeking a driven
QA Validation Engineer
to join Sligo base client on a contract basis to play a key role in ensuring site-wide validation and regulatory compliance.

About the Role

As a QA Validation Engineer, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards. This is a hands-on role that involves planning and executing validation activities, managing quality processes, and driving continuous improvement initiatives across equipment, utilities, processes, and software systems.

Key Responsibilities

• Develop, execute, and maintain Validation Master Plans and Project Validation Plans.
• Prepare and execute validation protocols, reports, and investigations to cGMP standards.
• Lead validation and quality assurance for site equipment, processes, and software.
• Support regulatory compliance through robust documentation, audits, and process improvements.
• Manage change control, exception events, and corrective actions.
• Provide cross-training, mentorship, and support to team members.
• Actively contribute to continuous improvement in manufacturing, quality, and safety systems.

Requirements:

• Degree in an engineering or scientific discipline.
• 3+ years' experience in validation/quality within medical device plastics processing, molding, or assembly operations.
• Strong knowledge of cGMP and medical device regulatory requirements.
• Excellent communication, organizational, and troubleshooting skills.
• Ability to work independently and as part of a team, with strong prioritization and multitasking skills.

For a confidential conversation about the role contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

Write, review and execute Validation Plans, Protocols and Reports for Albumin Projects ensuring compliance to all relevant global and local quality and validation procedures /standard.

Initial requirements to focus on the areas Equipment Qualification, Temperature Mapping (steam sterilisation), Aseptic Process Validation, Cleaning Validation and Process Validation to follow.

Represent Validation at technical forum include external and internal audits.

KEY RESPONSIBILITIES

• Write, review and execute Validation Protocols and Reports for Equipment Qualification, Aseptic Process Validation, Cleaning Validation, Process Validation, Temperature Mapping (steam sterilisation) and Equipment Software Validation, ensuring compliance to all relevant global and local quality and validation procedures/standards
• Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
• Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
• Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
• Development and execution of Process Validation protocols and reports (Cleaning Validation, APS, Process Validation and Continuous Process Verification).
• Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, and Maintenance) to execute qualification and validation efforts in support of site projects.
• Completion of risk assessments, closure of corrective and preventive actions (CAPA's)
• Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements
• Performs other validation associated activities as defined by Manager or Director.

KEY COMPETENCIES

• Temperature Mapping (steam sterilisation)
• Cleaning Validation.
• Process Validation
• Aseptic Process Validation
• Temperature Mapping (steam sterilisation), preferable
• Commissioning and Qualification
• Documentation (Writing SOPs, Protocols, Reports)
• Auditing
• Strong communication / presentation skills during internal/external audits.

PERSON SPECIFICATION

• Qualifications
• Project Management Experience
• Hands-on knowledge of execution of Validation (Min 2 years)
• Experience in a Quality or Validation Role within Pharma sector
• Experience within aseptic manufacturing environment
• Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
• Excellent Technical Writing and analytical skills.
• Familiarity with cGMPs and industry and federal guidelines required.
• Experience with Word, Excel and Access computer applications.
• Strong interpersonal skills for interactions with other departments.
• Degree in Science/Engineering and/or Min 2 years Validation experience
• Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
• Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
• Familiarity with ISO Cleanrooms and Associated Environments)
• Experience with Software validation for manufacturing

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates up to 7%
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Golf, Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

Location:Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3

Learn more about Grifols

Medical Device
Longford/Roscommon Ireland
CPL Recruitment are once again assisting our valued client source a
Validation Engineer
to join their team. This is an exciting opportunity to join a manufacturing site that has undergone major investment and expansion since 2022. You will be working with a very friendly and experienced team that have a wealth of experience in the leadership team.

Prior Medical Device And/or Injection Moulding Experience Essential.
Get in touch for further information : Deirdre Murphy on
/
or
(email protected)
Role

• Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
• Developing and implementing solutions to sustain and improve the QMS.
• Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
• Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
• Generation of risk assessments, covering cleaning, validation, and process.
• Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
• Directly supports GMP and regulatory audits.
• Prepare and deliver training modules as required.
• Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
• Support continuous improvement through Lean Six Sigma methodologies.
• Execution/ development of change controls.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.;
• Implement subsequent corrective action through the change management system.
• Participate/ lead cross functional teams including liaising with vendors on projects.

Requirements

• Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
• Experience in statistical analysis (Minitab) / SPC / validations.
• Excellent interpersonal, communication, influencing, and facilitation skills
• Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment essential.

We are seeking a Packaging Validation Engineer to join our client, a biopharmaceutical company based in East Cork. This role will play a critical part in ensuring packaging systems, equipment, and processes meet regulatory, quality, and safety standards. The successful candidate will support packaging validation projects, new equipment introductions, and continuous improvement initiatives across the site.

Responsibilities:

• Develop, execute, and maintain packaging validation protocols (IQ, OQ, PQ) in compliance with GMP, FDA, and EMA regulations.
• Lead validation activities for packaging lines, serialization systems, labelling equipment, and related automation.
• Support new product introductions by validating packaging configurations, artwork changes, and associated processes.
• Generate and review validation documentation, including risk assessments, validation plans, summary reports, and SOPs.
• Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Supply Chain) to ensure timely project delivery.
• Manage deviations, CAPAs, and change controls related to packaging systems.
• Monitor equipment and process performance, driving improvements in reliability and compliance.
• Stay current with regulatory expectations, industry standards, and emerging technologies in packaging validation.

Qualifications & Experience:

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 3+ years' experience in validation or engineering within a GMP-regulated environment (biopharmaceutical, pharmaceutical, or medical device).
• Strong knowledge of packaging operations (filling, labelling, serialization, tamper-evidence, etc.).
• Familiarity with regulatory guidelines (FDA, EMA, Annex 15, ICH Q9/Q10).
• Excellent documentation, analytical, and problem-solving skills.
• Proven ability to work independently and as part of a cross-functional team.
• Strong project management and communication skills.