54 Validation Engineer jobs in Ireland

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.

Summary: Our client is a global biopharma company based in Waterford looking for a Validation Engineer who 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. 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 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 dehydrogenation. Ensuring that the validation status of equipment and systems are compliant with cGMP at all times. Maintaining validation documentation through the validation lifecycle. Participation in external regulatory inspections. Support Site Change Control process. Qualifications & Experience: 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. Full understanding of relevant quality and compliance regulations. Able to execute projects to plan. Good knowledge of quality management systems. Ability to use MS Project and SPC packages an advantage. Understands KPIs for the site.

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

**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

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.

LSC have a great contract opportunity for Validation Engineer to join a leading Biopharmaceutical Facility in Louth. If you have 4 years of experience and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Execute qualification and validation activities for life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state. Author, review, execution and approval of testing protocols and reports. Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. ABOUT YOU - ARE YOUR SKILLS A MATCH? Bachelor degree, in a scientific or engineering field. A minimum of 3 - 5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function. Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments. Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently. Apply via this advert or contact Adam Murphy on if you have any more questions about this opportunity! Skills: GMP Validation Protocols Commissioning Qualifications

The Role 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. Job 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 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 process Skills 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. 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 Understands KPIs for the site. EET7373 If you would like to discuss this role in confidence,contactHarleen Tora/ Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply. eir evo talent, eir evo and our clients are equal opportunity employers who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data. If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo Skills: GAMP Validation ISPE

Were currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Execute qualification and validation activities for life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state. Author, review, execution and approval of testing protocols and reports. Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Will be flexible to take on additional tasks and responsibilities as requested. Will act as a role model for the Validation function and also the wider organization in adherence to the corporate core values. Education & Experience A minimum of 3 - 5 years experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function. Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers). Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.). Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment. Experience of equipment vendor package ownership and system design coordination. If interested in this posting please feel free to contact Sen McCarthy on or for further information.

Are you interested in taking the next step in your career with a leader in medical science? Are you ready to challenge yourself in a fast-paced and high-regulated environment? Are you an experienced engineer with a background in quality and validation? You could be the perfect candidate for this opportunity! Don't hesitate, apply today! Job Description Our client is seeking an experienced Quality Engineer who has proven success in quality and validation activities. You will provide quality support for site activities, ensure compliance with standards and collaborate with cross-functional teams. The ideal candidate will have experience in quality assurance and will have the ability to communicate effectively. You will be responsible for maintaining quality systems and continuous improvement initiatives. Key Responsibilities:Identifies and resolves complex exceptions to work assignmentsHas the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming productContinually seeks to drive improvements in product and process qualityKnowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisionsFully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaintsEvaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effectsCompiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processesMay participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirementsUses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve qualityPossesses excellent collaboration skillsGives technical guidance to Quality Technicians. Requirements:A Level 8 Degree or equivalent in an Engineering or Science-related disciplineA minimum of 2 years' experience working at Engineering level, ideally within the Medical Device industry or similar highly-regulated Experience with internal and external audit processesA team player, who can demonstrate best practices in line with the department and site objectives and someone who is fully motivated to achieve. BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidays. Location: Galway, Ireland | onsite