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Job Description
Technical Transfer Engineer (Fill Finish) with 4-5 years of experience in a GMP functional area or support, fill finish technical transfer experience, strong communication and teamwork skills, willing to travel 25-40%.
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide.
Responsibilities
- Work with External Partners to deliver technical transfer of our vaccine and biologics programs
- Responsible for technical activities for the commercial manufacturing process at the External Partner, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
- 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
- Ensure that External Partners are inspection-ready for all routine inspections
Requirements
- Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support
- 3-5 years fill finish Technical Transfer experience
- Travel will be a requirement of this position at approximately 25-40%
Preferred Experience and Skills
- Experience in Fill Finish activities
- Demonstrated ability to independently manage projects/work to schedule/deadlines
- Statistics experience