64 Process Validation jobs in Ireland

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

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

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.

Team Horizon is seeking a Validation Engineers for a leading pharmaceutical company in South Dublin. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: 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. Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT) and Performance Qualifications (PQs) associated with a Syringe Filling Line. Pre-Approve and Post-Approve validation protocols. Input into site Validation Master Plans and Standard Operating Procedures (SOPs) 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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES). Any other duties as assigned. What you need to apply: 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: Filling Line Validation E-Beam Technology FDA GMP Validation

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

**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

Position Overview: The Manufacturing Validation Engineer will play a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes in compliance with industry regulations and company standards in the medical device sector. This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion. The role requires a blend of engineering, regulatory knowledge, and leadership skills to drive successful project delivery, including documentation, risk management, and effective collaboration across cross-functional teams. Key Responsibilities: Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.). Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality. Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes. Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements. Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA). Develop and review validation protocols, reports, and SOPs (Standard Operating Procedures) to ensure all activities are properly documented and compliant with regulatory requirements. Ensure the traceability and audit readiness of all validation activities, supporting internal audits and regulatory inspections. Support the creation and review of regulatory filings and submissions as required. Ensure proper documentation practices, maintaining the highest standards for data integrity and quality assurance throughout the validation process. Actively participate in continuous improvement efforts within the manufacturing area to optimize equipment performance, reduce waste, and enhance operational efficiency. Provide training and mentorship to junior engineers or technicians, guiding them through validation protocols, equipment troubleshooting, and best practices. Contribute to lessons learned meetings and share insights to improve future validation processes. Lead and manage validation projects from conception through to completion, ensuring all aspects of the project adhere to defined timelines, budgets, and quality standards. Develop project timelines and schedules, ensuring all milestones are met and delivering the required project updates to senior management and stakeholders. Coordinate cross-functional teams, including Engineering, Quality Assurance, Manufacturing, Regulatory Affairs, and Suppliers, to ensure the success of validation projects. Conduct risk assessments for validation activities and ensure mitigation plans are in place. Track and report on the progress of validation projects and proactively address any potential delays or risks to project timelines. Prepare and maintain validation documentation and ensure compliance with company standards, including change control documentation, project status reports, and validation summaries. Skills: Bachelors or Masters degree in Engineering, Mechanical Engineering, Industrial Engineering,or a related field. 5+ years of experience in manufacturing equipment validation, qualification, or a related engineering role within the medical device or pharmaceutical industry. At least 2 years of experience in project management, leading cross-functional teams and driving complex projects to completion in a regulated environment. Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and cGMP. Expertise in validation practices (IQ/OQ/PQ) and associated documentation. Hands-on experience with manufacturing systems and equipment used in medical device production. Strong project management skills including the ability to create project timelines, track progress, and mitigate risks. PMP certification is a plus. Strong analytical and problem-solving skills, including root cause analysis and CAPA management. Ability to work collaboratively in a cross-functional team environment. Excellent communication skills, both written and verbal, with the ability to prepare detailed reports and present findings to management. Knowledge of industry-specific software, such as LIMS (Laboratory Information Management Systems), ERP (Enterprise Resource Planning), or Veeva Vault, is a plus. Familiarity with risk management principles (e.g., FMEA, Risk Assessment) and their application in equipment validation. Skills: validation manufacturing IQOQPQ Equipment qualification risk assessment verification manufacturing engineer

Validation Engineer - Kerry An opportunity is now available for a Validation Engineer with duties to include Review of all IOQ documentation generated by C&Q vendor. Preparation, execution and summary reports from PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, Warehousing. Support and review of documentation from Calibrations and Thermal Mapping Vendors. Responsibilities: Evaluation of validation requirements including areas of new equipment, change controls, new requirements. Monitor status of projects and get updates where required, from a validation perspective. Provide support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings. Liaise with project managers to ensure project schedule is adhered to. Assessment of current practices to ensure compliance with cGMP requirements. Review/Implementation of procedures, reports, results etc. for compliance. Review/ Implementation of both global and AICL, CSV documentation. Responsible for the coordination of SDLC Documentation. Review and approval of all projects validation protocols plant wide. Review and approval of project change controls. Provide input into the development of company validation standards. Arcadis | DPS Group is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.

Orange Recruitment are sourcing Quality professional looking to make a meaningful impact within a forward thinking and regulated manufacturing environment. We're seeking a proactive and detail-focused Quality Validation Engineer to join our clients growing team in supporting compliance, process validation, and continuous improvement in alignment with global quality standards. Responsibilities Ensure the implementation, upkeep, and continual improvement of the company's Quality Management System in compliance with relevant ISO and MDR standards. Lead and support validation activities (IQ/OQ/PQ) for new and existing processes, including protocol development, execution oversight, and data evaluation. Coordinate and perform internal quality audits, helping to drive best practices and ensure audit readiness at all times. Act as a critical support member during customer and regulatory audits, providing documentation and expert input as needed. Collaborate with cross-functional teams in product development, including process trials and first production runs. Investigate and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies. Monitor supplier performance and initiate NCMRs and corrective actions as needed, preventing defects from reaching final product stage. Compile, analyse, and report quality metrics to leadership and stakeholders, contributing to the continuous improvement strategy. Assist in the creation and revision of Standard Operating Procedures (SOPs), work instructions, and quality documentation. Requirements Degree-qualified in Engineering, Science, or a related technical discipline. Minimum of 3 years' experience in a quality-focused role within a regulated manufacturing environment, ideally medical devices or life sciences. Certified Internal Auditor (ISO 13485) with hands-on experience leading or participating in audits. Solid working knowledge of equipment validation, risk-based approaches, and statistical analysis. Strong understanding of non-conformance handling, CAPA processes, and change control. Meticulous attention to detail with excellent problem-solving and documentation skills. Ability to communicate clearly across functions and work effectively both independently and as part of a team.