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CQV Engineer (cGMP - Pharmaceutical)

AM Technical Solutions, Inc

AM Technical Solutions, Inc

Posted on Thursday, January 26, 2023

We are looking for multiple CQV Engineers to join our Life Sciences team 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.

Roles and 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.

Position Requirements and Qualifications:

  • 3+ years professional experience in a biologics/pharmaceutical.
  • Experience developing and executing process, equipment, and 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.

Education:

Bachelor’s degree (preferably in an engineering discipline) or relevant scientific or related discipline.