The CQV Engineer will support commissioning, qualification, and validation activities for HVAC and Utilities in large scale Pharmaceutical Facility.
Key Responsibilities:
* Work closely with the Area CQV Lead to plan, prepare, and execute commissioning and validation activities for Utilities
* Develop and execute CQV testing documentation for Utilities and HVAC systems
* Deliver key project milestones related to safety, CQV schedule, and quality of documentation/electronic records.
* Ensure testing of GMP equipment, Utilities, and HVAC systems is performed in compliance with GMP requirements, company policies, and EU/FDA regulations.
* Ensure all Utilities, and HVAC systems are commissioned and tested in line with project standards.
* Lead or support management of deviations related to assigned systems and utilities.
* Identify and assess CQV risks; develop and implement mitigation plans.
* Execute FAT testing and incorporate results into the overall qualification lifecycle.
* Complete all required training in line with project and site metrics.
* Work effectively within a diverse CQV team to deliver work safely, on schedule, and within budget.
Required Competencies:
* Proven ability to execute CQV activities from initiation through handover.
* Strong experience in the CQV project lifecycle: design, commissioning, qualification, and validation.
* Demonstrated experience with HVAC systems in controlled environments.
* Experience with Utilities, including:
* High Purity Water systems
* Purified Water & WFI generation/distribution
* Clean Steam
* High Purity Gas Systems
* Strong documentation, execution, and task planning skills with consistent on-time delivery.
* Excellent communication and stakeholder influencing skills.
* Experience working in matrix teams and cross-functional project environments.
* Familiarity with electronic validation systems (e.g., ValGenesis, Kneat).
Qualifications & Experience:
* Bachelor's degree in a scientific, engineering, or technical discipline (minimum requirement).
* Minimum 5 years' experience in the pharmaceutical industry
* Proven experience in CQV of HVAC and Utility Systems