Engineer CQV_BLS

The Engineer CQV (Commissioning) executes and documents system-level commissioning activities for BLS / Pharmaceutical projects, ensuring assigned facilities, utilities, equipment and controls are safely completed, tested and prepared for turnover in accordance with approved procedures, project requirements and applicable cGMP expectations.
Reporting to the Commissioning Manager, the role supports systemization, completion verification, pre-commissioning, vendor start-up, functional testing, deficiency resolution and handover. The Commissioning Engineer works closely with Engineering, Construction, Quality, EHS, subcontractors, OEMs and Client CQV/Validation representatives and maintains accurate, traceable commissioning records.
The role performs commissioning and verification activities within the approved contractual scope. Qualification or validation protocols are supported or executed only when assigned and approved by the Client and project leadership.

* Plan and execute commissioning activities for assigned BLS / Pharma systems in accordance with approved procedures, schedule, safety controls and acceptance criteria.
* Verify construction and Mechanical Completion readiness; review check sheets, test records, punch items and turnover package completeness.
* Coordinate and witness pre-commissioning, vendor start-up, calibration, loop checks, functional testing and performance verification.
* Maintain accurate commissioning records, completions-system status, deficiencies, deviations, test evidence and turnover documentation.
* Report progress, constraints, risks and resource needs to the Commissioning Manager and drive timely technical resolution and punch closure.
* Develop detailed work plans, procedures, check sheets, test scripts and commissioning records for assigned systems using approved project templates.
* Review drawings, specifications, P&IDs, equipment data, control narratives, cause-and-effect matrices and vendor documents for testability and commissioning requirements.
* Support system and subsystem boundary definition, tagging, walkdowns, turnover sequencing and commissioning schedule development.
* Perform or witness completion checks, flushing, cleaning, pressure/leak testing, energization, calibration, loop checks, balancing, start-up and functional/performance tests, as applicable.
* Coordinate field activities with construction teams, subcontractors, OEMs, controls integrators, testing agencies and Client representatives.
* Verify that required permits, risk assessments, LOTO, energization controls, temporary utilities and safe work prerequisites are in place before execution.
* Record test results and objective evidence; identify failures, deficiencies, deviations and punch items and support root-cause evaluation and retesting.
* Update the completions management system and maintain current status for assigned systems, documents, constraints and punch items.
* Compile and review turnover packages, including approved tests, certificates, vendor records, calibration data, as-built information and exception lists.
* Support FAT/SAT activities, vendor coordination, training, O&M documentation and handover to Client/Operations.
* Apply project Good Documentation Practices and data-integrity requirements to all commissioning records.
* Support Client CQV/Validation execution, discrepancy resolution and evidence retrieval when included in the approved scope.
* Participate in readiness reviews, coordination meetings, lessons learned and continuous-improvement activities

• Bachelor's degree in Mechanical, Electrical, Chemical, Process, Controls or related Engineering discipline; equivalent relevant technical experience may be accepted.
• 5 years of commissioning, start-up, field engineering or CQV experience, including experience on BLS / Pharmaceutical, biotechnology or other regulated life-science facilities.
• Hands-on experience with at least one relevant discipline such as HVAC/BMS, mechanical and clean utilities, process-support systems, electrical systems, instrumentation or controls/automation.

Preferred

• Experience on greenfield and/or brownfield projects, including work in or adjacent to operating GMP facilities.
• Commissioning, controls, electrical, mechanical or CQV certification/training.
• Experience with electronic completions management and digital turnover systems.
• Working knowledge of commissioning, system completion, turnover, start-up and the interface with qualification and validation inBLS / Pharmaceutical projects.
• Working knowledge of cGMP, Good Documentation Practices, data integrity and risk-based verification principles.
• Ability to interpret relevant drawings, specifications, P&IDs, schematics, sequences of operation, control narratives and vendor manuals.
• Ability to write clear procedures and test records, troubleshoot system performance and document objective evidence.
• Strong field coordination, planning, problem-solving, communication and organizational skills.
• Proficiency with common office applications and electronic commissioning/completions tools; proficiency in English required.
  Essential:
• Safety-focused field execution and compliance with approved work controls.
• Technical rigor, attention to detail and disciplined documentation.
• Ownership of assigned systems, transparent reporting and timely escalation.
• Collaborative working style across disciplines, vendors, trades and Client teams.
• Structured troubleshooting and persistence through testing and punch closure.
  Desirable:
• Experience supporting GMP turnover, risk-based verification and qualification activities.
• Ability to coordinate small multidisciplinary field teams for assigned systems.
• Project-site based assignment with travel to vendors, fabrication facilities and other project locations as required. Willingness and ability to remain on site for extended periods and to work outside normal hours during critical testing, start-up and turnover windows.

You want to be part of the Exyte team? We look forward to receiving your application!
For further questions and information, please do not hesitate to contact Clinton Crellin via E-Mail at clinton.crellin@exyte.net.

Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.