What are the responsibilities and job description for the Project Engineer position at TekOne IT Services Pvt. Ltd.?
Title: Project Engineer
Location: Andover , MA
Job Description
Location: Andover , MA
Job Description
- The Tech Transfer Engineer II will be joining the Andover Clinical Manufacturing Facility (ACMF) team.
- The ACMF is a facility located on the Pfizer Andover, MA campus and is responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The ACMF resides within the Research and Development organization.
- The ACMF Tech Transfer Team is responsible for incoming product site assessment, preparatory activities, campaign readiness, and overall product/project ownership to support ACMF manufacturing of clinical drug substance.
- Execute tech transfer activities in support of all ACMF campaigns
- Work with development lines to improve scale up processes and identify best TT practices
- Partner with development lines on complex technical initiatives
- Lead/support the creation of manufacturing batch records and other GMP documentation
- Execute and troubleshoot upstream and downstream processes in a cGMP environment
- Authorship of SOPs for upstream and downstream unit operations
- Data analysis and communication/collaboration with tech transfer team, production operations, development labs, and quality
- Support implementation of new technologies and equipment
- Support and author investigations as needed
- Support facility audits as needed
