This position is responsible for leading and coordinating CQV project activities for all HVAC systems and Facility Qualification, aligning with the overall project strategy. The CQV Engineer will support all project functions related to HVAC and Facilities, working closely with teams in Utilities, Process Engineering, Operations, Engineering, Quality Operations, EHS, Logistics, Lean, Digital, and the Project Microbiologist Representative to understand functional requirements and to develop and implement the best commissioning and validation approach.
Main Duties and Responsibilities
Oversee CQV activities for HVAC systems and Facility Qualification, ensuring timely execution and adherence to industry standards.
Develop, review, approve, and execute commissioning and qualification activities, managing issues efficiently and in compliance with project procedures.
Prepare, review, and approve documentation including Commission and Validation Plans, URS, IOC, Close-out Reports, and related records.
Manage and coordinate HVAC system equipment and Facility Qualification commissioning and qualification tasks.
Review and approve vendor and field turnover documentation for all HVAC and Facility Systems equipment.
Serve as the CQV point of contact between clients, internal teams, and external vendors to ensure project success.
Provide technical guidance and collaborative resolution for issues as they arise.
Identify and mitigate project risks while ensuring deliverables meet required quality and compliance standards.
Qualifications/Skills and Experience Required
Thorough understanding and demonstrated experience with the deployment and execution of Risk-Based Commissioning processes following ISPE guidelines, within large Capex environments.
Experience working with digitized commissioning and qualification platforms (e.g. Kneat Solutions) is desirable.
Solution-oriented mindset suited to fast-paced, dynamic settings.
Experience with systems such as AHUs, chilled water, heating hot water, as well as Clean Rooms, Corridors, Personnel Air Locks (PALs), and Material Air Locks (MALs).
Prior experience as a senior CQV Engineer with a technical background.
Relevant degree and/or at least 10 years of experience in biotech or pharmaceutical industry commissioning GxP systems.
Strong knowledge of regulatory requirements (EU and other agencies) to ensure CQV activities comply with all necessary guidelines.
Excellent verbal and written communication skills and experience in developing strong interdepartmental relationships.
Highly analytical with strong problem-solving skills; dynamic decision maker and effective planner.
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