I'm looking for a Sr. Validation Engineer for a large-scale Fill Finish Project in the Biopharmaceutical Industry. This person will ensure the Syringe Filling Line Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality.
This is a 12-month hourly rate contract position.
Responsibilities:
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
- Generation , review and approval of Validation Plans, FAT, SAT IV/FTs, QRAES, PQ's associated with a Syringe Filling Line.
- Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
- Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
- Input into site change controls.
- Reviews and Approves all C&Q summary reports and Validation Summary reports.
- Pre-Approval and Post approval of Validation test documents.
Requirements:
- Previous experience with Qualifying a Syringe Filling line that utilises Isolator Technology.
- BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality.
- Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
- Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
- Demonstrated strong Communication and Leadership skills.
- 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 Clean Utility Systems.
- Strong collaboration and communication skills.
