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.
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Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment.
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Develop and review qualification protocols, test documentation, and validation reports.
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Writes and revise GMP and GDP documents and technical specifications.
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Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle.
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Support development of SOPs and review final reports.
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Collaborate with Engineering, Quality, Manufacturing, and Project teams to ensure successful project delivery.
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Mentoring and providing consultation to the client and local team.
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Ensure compliance with cGMP requirements, regulatory standards, and company quality systems.
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Responsible for managing project activities and timelines.
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Provided status reports of projects to the PSC Project Manager.
Requirements:
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Bachelor Degree in Engineering, Science, or a related discipline.
5+ years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
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Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach.
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Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
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Proficient in developing SOPS, final reports and validation & quality policies.
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Understanding, developing, executing and maintaining CQV procedures and policies.
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Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo.
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Experience performing temperature mapping and qualification of benchtop autoclaves.
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Experience with digital validation platforms, preferably Kneat.
