My client is a global biotech company based in the East Coast (Providence, RI). Their goal is to create transformative medicines for people with serious & life-threatening diseases. They are looking for a Qualification Equipment Engineer/CQV to join their team on a contractual basis of 6 months w/ extension possibilities. The main responsibility of a CQV is to validate existing manufacturing equipment and processes as the company prepares to begin clinical development.
Location: Providence, RI (Hybrid)
Role: Qualification Equipment Engineer/CQV Engineer
Length: 6-month contract w/ extension possibilities
Key Responsibilities:
- Create and facilitate quality system documentation to establish good validation practices within the organization
- Design validation approaches, perform all validation activities, gather and analyze results, and create validation reports
- Act as SMR and provide input on functional requirements of current or future processing equipment, and draft necessary documentation
- Work alongside other teams such as the R&D and Manufacturing team, in order to ensure successful technology transfer and streamline processes
Qualifications:
- S / M.S in engineering preferred
- 5+ years of experience in a medical device or FDA regulated environment
- Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.),
- Understanding of c.G.x.P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
- Working knowledge GAMP 4 and GAMP 5 categorization and their respective deliverables for Computer Systems Validation lifecycle