Principal Validation Engineer – Facilities/Equipment

Junto HLS has been engaged by a Top 20 pharma client to recruit a Principal Validation Engineer – Facilities/Equipment.

Position Overview:

  • Lead and perform variety of CQV projects/studies in areas that may include Product/Process, sterilization, Cleaning verification and Equipment commissioning and qualification, as well as projects/studies to support manufacturing.
  • Supports the Commissioning, Qualification and Validation (CQV) for all aspects of the manufacturing facility including bioreactors, centrifuges, chromatography systems, CIP skids, SIP Operations, and clean utilities (water and steam).
  • Provide leadership in scheduling, planning and execution of validation projects for plant utilities, facilities and process equipment.
  • Define CQV strategies and oversight through the implementation of CQV plans for plant utilities, facilities and process equipment.
  • Apply thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management, and other training as appropriate.
  • Plan CQV projects and track execution of CQV activities/documentation versus project timeline.  Manage and plan work of the internal and contract resources.
  • Perform change control assessments and write/review CQV plans, study/test protocols, and summary reports.  Manage execution of study/test protocols and review test results.
  • Collaborate closely with Engineering and Process sciences in defining the role of suppliers with the assessment of suppliers and oversight of supplier activities and documentation related to Commissioning activities.
  • Mentor junior staff in their job performance and project related activities.
  • Support development of best demonstrated CQV practices within the validation department, based on current industry practices and regulatory guidelines.
  • Develop, complete, log and archive CQV documentation

Location(s):

    • Greater Minneapolis, MN

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.