NH: CSV Project Lead (235248)

Life Sciences & Technology


  • 12 months plus

Job Description:

  • CSV experience of 10+ years
  • Strong knowledge in validation lifecycle of Facilities, Utilities, Process Equipment, Computerized Systems and Analytical Instruments.
  • Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
  • Provide any necessary training as required for the project CSV engineers.
  • Leading the project
  • Serve as the overall 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 course of project.
  • Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11and 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 oversite on engineering change controls and automation changes
  • Experienced at working independently as well as in a team-oriented, collaborative environment is essential
  • Experience with Kneat is needed
  • Strong verbal and written communication skills
  • Support projects during regular work hours with some overtime as needed.

Required Skills:

  • CSV Project Lead
  • Computer Systems Validation
  • Kneat
  • Automation


NH: CSV Project Lead (235248)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
New Hampshire

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