Job Details

All Jobs / Req# NOVRJP00007901
Req Number:
Req Title:
Senior Engineer/Eng. Team Leader
A Major Pharma Company
Work Address:
San Diego, CA
Req Release Date:
12 months
Hours a week:
40 Hours
Position Summary

Title: Validations Specialist-Commissioning and Qualification


  • Reports on progress and roadblocks to the project team.
  • Develop relevant protocols, execute protocols, and own C&Q activities for the decommissioning project for the commercial QC lab in San Diego
  • Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and end of life periodic reviews
  • Liaise with client end user groups to ensure project is successfully completed per industry and the Client guidelines.
  • Validation using risk-based approach (FMEA, PHA, etc.)
  • Authors and reviews project documentation, as needed. (URS, FRS, Technical Specifications, Functional Specifications)
  • Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information
  • Partners with Quality to ensure a quality and compliant environment
  • Other related duties as assigned.

Top Three Skills: 

  • QC laboratory or manufacturing instrument background (especially commissioning and qualification)
  • Calibration management – specifically engineers with calibration experience so they can help us close out WOs
  • Experience in GMP environment, Pharma/Med-Device is a must (Pharma preferred)


  • Bachelor’s degree in Engineering, Science or related technical field.
  • 4+ years of experience in pharmaceutical or biotechnology GMP manufacturing performing commissioning and qualification (C&Q) or equipment validation activities.
  • Ability to read/interpret engineering drawings and design documents
  • Excellent technical writing and verbal communication skills
  • Must be able to work independently and successfully plan to
  • Must be people oriented and a team player
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
  • In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211
  • Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
  • They are also looking for candidates with 5-8 years of experience .
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