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PSC Biotech® Corporation
C&Q EngineerPSC Biotech® Corporation • Melbourne, AU
C&Q Engineer

C&Q Engineer

PSC Biotech® Corporation • Melbourne, AU
30+ days ago
Job description

POSITION SUMMARY:

The C&Q Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility.

Key Responsibilities:

  • Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment.
  • Develop and review qualification protocols, test documentation, and validation reports.
  • Writes and revise GMP and GDP documents and technical specifications.
  • Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle.
  • Support development of SOPs and review final reports.
  • Collaborate with Engineering, Quality, Manufacturing, and Project teams to ensure successful project delivery.
  • Mentoring and providing consultation to the client and local team.
  • Ensure compliance with cGMP requirements, regulatory standards, and company quality systems.
  • Responsible for managing project activities and timelines.
  • Provided status reports of projects to the PSC Project Manager.

Requirements:

  • Bachelor Degree in Engineering, Science, or a related discipline.
  • 5+ years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
  • Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach.
  • Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
  • Proficient in developing SOPS, final reports and validation & quality policies.
  • Understanding, developing, executing and maintaining CQV procedures and policies.
  • Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo.
  • Experience performing temperature mapping and qualification of benchtop autoclaves.
  • Experience with digital validation platforms, preferably Kneat.

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C&Q Engineer • Melbourne, AU

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