Leads commissioning, qualification, and validation activities for GMP-regulated systems, facilities, and equipment. Authors and executes DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation; develops SOPs, validation reports, and quality policies; supports temperature mapping and autoclave qualification; coordinates project timelines and stakeholders; and ensures compliance with cGMP, regulatory standards, and quality systems.
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
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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