This role involves leading and coordinating CQV project activities for all Black Utility area systems according to the project’s overall strategy. The CQV Engineer will collaborate across various project functions, focusing on black utilities, and will work closely with HVAC, process engineering, Operations, Engineering, Quality Operations, EHS, Logistics, Lean, and Digital teams to understand functional requirements and design and implement optimal commissioning and validation strategies.
Main Duties and Responsibilities
Lead CQV activities for black utility systems, ensuring timely execution and adherence to industry regulations.
Develop, review, approve, and execute commissioning activities, efficiently addressing issues found during execution in compliance with project procedures.
Prepare, review, and approve documentation such as Commission Plans, SRA, URS, IOC, Close-out Reports, etc.
Coordinate Black Utility system equipment commissioning activities.
Review and approve vendor and field turnover documentation for equipment associated with Black Utility Systems.
Serve as the CQV point of contact between clients, internal teams, and external vendors to ensure project success.
Provide technical oversight and guidance to collaboratively resolve issues.
Identify and reduce project risks, ensuring deliverables meet required quality and compliance standards.
Qualifications/Skills and Experience Required
Demonstrated understanding and experience in deploying and executing a Risk-Based Commissioning process in accordance with ISPE guidelines within a large Capex environment.
Experience working with digitized commissioning and qualification platforms (e.g., Kneat Solutions).
Solution-oriented mindset in a fast-paced, dynamic setting.
Experience with systems such as Mains Water, Plant Steam & Condensate, Instrument Air, Cooling Water Generation & Distribution, Chilled Water Generation & Distribution, Vents, and Natural Gas.
Prior experience as a senior CQV Engineer with technical expertise.
Relevant degree and/or 10+ years of experience in the biotech or pharmaceutical industry qualifying GxP systems.
Strong knowledge of regulatory requirements (EU and other bodies) to ensure CQV activities meet required standards and guidelines.
Excellent communication skills, both verbal and written, with experience building strong interdepartmental relationships.
Strong analytical and problem-solving skills; dynamic decision-maker, effective planner, and communicator.
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