PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
Job Summary
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 Responsibilities
* 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 & Qualifications
* 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/standards.
* Solid understanding of process equipment, clean utilities, black utilities, and HVAC system operations.
* Strong analytical, documentation, and organizational skills.
* Effective interpersonal and communication skills for collaborative work environments.
* Proficiency with standard business and documentation software (e.g., MS Office).
* Willingness to travel and participate in on‑site fieldwork as required.
* Professional certifications (e.g., ISPE, CQV‑related) desirable but not required.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Industries
Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research
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