This is Satya Chittidi from Intellectt INC; we have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to satya.c@intellectt.com or call me at +1 732 997 6982.
Title: CSV Project Lead
Location: New Hampshire, MA
Duration: 12 months plus
Job Description
Strong knowledge in validation lifecycle of Facilities, Utilities, Process Equipment, Computerized Systems, and Analytical Instruments
Familiarity with biologics (mammalian, CGT) and chemical manufacturing technologies desirable Provide necessary training for project CSV engineers
Lead the project
Serve as the Lead Engineer / Liaison for the C&Q and CSV Teams
Support C&Q / CSV lifecycle and testing document reviews and approvals throughout the project
Provide technical SME input for document development and testing activities
Drive resolution of testing incidents, engineering changes, and automation changes
Support management of CSV project controls and progress reporting
Assist C&Q manager in developing/updating CSV timeline throughout the project
Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11 and Data Integrity
Provide high-level guidance/strategy for CSV activities
Review and approve CSV Documentation (URS, FS, DQ, IV/IQ, OV/OQ, OPQ, and Summary Reports) as required
Provide CSV oversight on engineering change controls and automation changes
Experience working independently as well as in a team-oriented, collaborative environment
Experience with Kneat is essential
Strong verbal and written communication skills
Support projects during regular work hours with some overtime as needed
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Other
Industries
Pharmaceutical Manufacturing
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