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Commissioning & Verification Consultant
2 months ago
Role: Commissioning & Verification Consultant (CQV)
Location: Kalamazoo, MI, 49001
Duration: Long Term Contract
Job Description:
Our client is seeking Commissioning & Verification (C&V) resources to draft and execute testing and documentation of the MAP Mod 1 equipment. It is understood that the equipment is installed at varying stages in the verification and documentation phases. The client would pick up the current state and progress deliverables depending on the execution stage for each piece of equipment. The client will lead priority and direction.
Draft and execute Verification Testing protocols.
Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned
workstream. This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), specifically focusing on GMP-critical aspects and impact on commissioning & verification.
Review and assess vendor documentation and execute testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
Lead and participate in the development and execution of complete verification documentation in accordance with Client Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
Collaborate with other work stream leads to ensure effective integrated systems and equipment verification strategy.
Provide or arrange for the development of complete verification documentation in accordance with Client Quality Standards and cGMP requirements for assigned work stream.
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