Lead Validation / CSV Engineer

Location: San Mateo, California
Date Posted: 12-11-2018
Title: Senior Validation Engineer

Type of role: Contract
Duration: 12-24+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: San Francisco Bay Area

Seeking a Senior Validation Team member who could plan, lead, and complete overall validation efforts within given timelines.  Work with team members for collaborating other parts of project such as infrastructure planning, system integration planning, user training, and planning for next phase of system.

Must have strong experience in the following:
  1. Hands on experience with laboratory instrumentation and CSV
  2. Well versed in developing validation deliverables per company procedure and standards.
  3. Strong interpersonal, communication, and technical writing skills.
  4. Experience with managing instruments and system throughout the lifecycle.
  5. Experience on Brucker NMR, PXRD, and other standalone instruments would be a great plus.
  6. Participates on cross-functional project teams with the support of Development, Quality, and other groups
  7. Familiar with FDA guidelines for Instrument and Software validation.
  8. Experience must come from a pharmaceutical, biotech industry with direct knowledge of FDA regulations including 21CFR Part 11.
  9. Self-motivated, good communication, technical writing, presentation skills, detail oriented, analytical, and a team player.

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