Senior CQV Engineer

The CQV Engineer is responsible for supporting and executing Commissioning, Qualification, and Validation (CQV) activities across a wide range of systems—including HVAC, utilities, and process equipment—in regulated industries such as pharmaceuticals, biotechnology, or life sciences. This role ensures systems are installed, commissioned, qualified, and validated in line with project requirements, regulatory guidelines, and industry standards. The CQV Engineer collaborates closely with project teams, contributes to documentation, and actively participates in field execution.

MAIN RESPONSIBILITIE

Develop, review, and execute CQV documentation including commissioning (FAT/SAT), qualification protocols (IQ/OQ/PQ), test plans, and validation reports for multiple systems (HVAC, utilities, process equipment, and others)

Participate in and support field execution of commissioning and qualification testing, ensuring accurate data collection, evaluation, and reporting

Assist in troubleshooting, resolution of issues, and investigation of deviations during system start-up and qualification

Collaborate with engineering, construction, operations, and quality teams to ensure seamless project execution

Ensure adherence to cGMP, FDA, EU, ISPE, and other regulatory standards relevant to system validation

Assist with project scheduling, coordination of vendors/contractors, and inventory of required materials/parts for CQV activities

Maintain robust, compliant, and traceable documentation of all CQV processes

Attend and contribute to project meetings and provide status updates as required

Support preparation for and participation in regulatory inspections and client audits

Identify opportunities for improvement and contribute to best-practice CQV procedures

EDUCATION/QUALIFICATIO

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field) or equivalent technical discipline

Minimum 5 years of CQV experience in a regulated industry (pharmaceutical, biotechnology, medical device, etc.), covering multiple systems: process, utilities, and/or HVAC

Demonstrated experience with development and execution of CQV protocols and documentation (FAT/SAT, IQ, OQ, PQ)

Familiarity with cGMP, FDA, EMA, ISPE Baseline Guides, and related regulations/standard

Solid understanding of process equipment, clean utilities, black utilities, and HVAC system operation

Strong analytical, documentation, and organizational skill

Effective interpersonal and communication skills for collaborative work environment

Proficiency with standard business and documentation software (e.g., MS Office)

Willingness to travel and participate in on-site fieldwork as require

Professional certifications (e.g., ISPE, CQV-related) desirable but not require

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