The main responsibility of a CSV is to validate equipment and processes used to produce medical devices. Upon speaking with the hiring manager, an ideal candidate is one with equipment software validation experience and at least 5 years of experience working within a medical device or FDA regulated environment.
Location: Providence, RI (Hybrid)
Role: CSV - Equipment Software Validation 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, to ensure successful technology transfer and streamline processes
Qualifications:
- B.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