C&Q Engineer

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.