Validation Lead - Fill Finish
12 month contract
South Dublin
AMC3472


I am on the lookout for a Validation Lead for a large scale, Fill Finish project with one of my Biopharmaceutical clients. In this role you will lead a team of Validation engineers to ensure that a large fill finish project is a completed safely, on time and in compliance with GMP and Quality Requirements.

If you have a relevant degree along with 7+ years in Validation in the pharmaceutical and biopharmaceutical industry this could be the role for you!

Key responsibilities:

• Oversee and coordinate all validation activities.
• Approve validation planning documents outlining the overall project strategy.
• Develop and approve the master list of validation test documents and activities.
• Review and approve all Commissioning & Qualification (C&Q) summary reports and validation summary reports.
• Ensure the validation schedule is established and maintained.
• Verify that all validation engineers conducting validation activities have the necessary training.
• Manage the pre-approval and post-approval of validation test documents.
• Organize and lead validation coordination meetings.
• Track and report on validation status, including risks and issues.
• Assist in developing User Requirement Specifications (URS) and conducting Quality Risk Assessments for equipment and automated systems (QRAES).

• Bachelor of Science or equivalent degree
• 7+ years experience gained in Validation, Engineering, Microbiology or Quality
• Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
• Sterile/Biotech equipment validation experience
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
• Working knowledge of sterilization/decontamination systems and industry practices.
• Experience with AVS (Airflow Visualization) Studies.
• Experience of aseptic processing