We are seeking a CQV Utilities Engineer to join Adryan and support the commissioning, qualification, and validation of critical utility systems at a pharmaceutical client site. The role focuses on GMP-compliant utility systems including WFI, Purified Water, Clean Steam, Compressed Air, HVAC, and other facility support systems. The ideal candidate will bring technical expertise, regulatory knowledge, and a hands-on, client-focused mindset.
Key Responsibilities
* Plan, execute, and document CQV activities for utility systems and regulatory requirements.
* Develop and review URS, FS, DQ, FAT, SAT, IQ, OQ protocols for GMP utilities (WFI, PW, HVAC, CDA, etc.).
* Perform field walkdowns, generate punch lists, and lead equipment/system startup and troubleshooting.
* Coordinate with project management, engineering, QA, validation, and vendors to ensure project timelines and deliverables are met.
* Support deviation investigations, change controls, and resolution of non-conformances.
* Ensure alignment with current GMP, GEP, ISPE Baseline Guides, and FDA/EMA regulations.
* Contribute to risk assessments and impact assessments for utility systems.
* Provide technical input during design reviews, commissioning, and validation strategy meetings.
Required Qualifications
* Bachelor’s degree in Engineering (Mechanical, Chemical, Process, or related field).
* 4+ years of CQV or validation experience in GMP-regulated pharmaceutical or biotech environments.
* Strong knowledge of utility systems (Clean Utilities, HVAC, Process Gases, etc.) and associated equipment.
* Familiarity with ISPE Baseline Guides, FDA, EMA, and ICH guidelines related to utilities and CQV.
* Experience writing and executing IQ/OQ protocols and supporting validation documentation lifecycle.
* Excellent communication, collaboration, and problem-solving skills in English.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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