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Job Description
Technical Transfer Engineer (Fill Finish) job requires 4-5 years of experience in GMP functional areas, with 3-5 years of fill finish technical transfer experience.
PSC Biotech is a leading Biotech Consultancy firm with global operations, providing cloud-based software solutions for Quality Management and Regulatory Inspections.
Job Summary: We are seeking a highly motivated individual to participate in technology transfers, commercial production of sterile drug product, and process optimization.
Responsibilities:
- Work with External Partners to deliver technical transfer of vaccine and biologics programs.
- Responsible for technical activities for commercial manufacturing process at External Partner, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation and regulatory filings.
- Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
- Ensure that External Partners are inspection-ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
- Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Required Education, Experience and Skills:
- Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area.
- Must have 3-5 years fill finish Technical Transfer experience.
- Travel will be a requirement of this position at approximately 25-40%.
- Strong communication and teamwork skills.
Preferred Experience and Skills:
- Experience in Fill Finish activities – (Vial/Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
- Demonstrated ability to independently manage projects/work to schedule/deadlines.
- Statistics experience (including Proactive Process Analysis and Continuous Process Verification).
- Experience in deviation management and/or change control and/or equipment support, and/or project management.