61 Validation Engineer 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 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.

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 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.

Our client is seeking a QA Validation Engineer to join their team at their Sligo Facility. Responsibilities To coordinate the development and maintenance of the site validation program and ensure AbbVie 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. 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 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 Essential 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. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation