Validation Engineer (12 Month Contract)

Validation Engineer (12 Month Contract)

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-14644 (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