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Commissioning/Validation Engineer (cGMP - Pharmaceutical) JD817697

JD817697

DPS is looking for multiple CQV resources to support major projects for various pharmaceutical clients in the Boston, MA and Southern NH areas. This individual will write and execute validation protocols for new and existing, facility utilities, and process equipment.

Category:
Engineer Commissioning & Qualification
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
31/05/2019
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Validation Engineer (cGMP - Pharmaceutical)       JD817697

Boston, MA area

 

Summary:

DPS is looking for multiple CQV resources to support major projects for various pharmaceutical clients in the Boston, MA. This individual will write and execute validation protocols for new and existing, facility utilities, and process equipment.

 

Responsibilities:

  • Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes.
  • Start-up C&Q experience of process and utility systems.
  • Be able to work as part of a large project team and be a system owner for a system.
  • Role will involve authoring and executing CQV documentation for a defined system against project schedule and timelines.
  • Deviation/Nonconformance write up and close out resolution.
  • Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems and utilities to ensure thoroughness, accuracy and compliance with company policies.
  • Provide technical troubleshooting and creative solutions to manufacturing process challenges.

 

Qualifications:

  • Bachelor’s degree (preferably in an engineering discipline).
  • Relevant engineering, scientific or related discipline.
  • 5+ years professional experience in a biologics/pharmaceutical.
  • Experience developing and executing process, equipment, and cleaning validation protocols.
  • Knowledge of cGMP practices and standards.
  • Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results oriented, team mindset and capable of changing direction and focus as priorities shift.
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