Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
Key Responsibilities:
- Coordinates and Supervises all Validation activities
- Approves Validation planning documents detailing overall strategy for the project.
- Develops and approves the master list of Validation test documents and activities.
- Reviews and Approves all C&Q summary reports and Validation Summary reports.
- Ensures the Validation schedule is developed and maintained.
- Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
- Pre-Approval and Post approval of Validation test documents.
- Manages Validation coordination meetings.
- Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
Education / Experience:
- 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.
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
- 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
