CQV Engineer – Role Overview
The CQV Engineer is responsible for overseeing the defined scope of allocated black utilities, clean utilities, and HVAC systems, ensuring alignment with agreed objectives in terms of safety, schedule, and functionality, in accordance with Commissioning Plans and Protocols.
Responsibilities:
* Primary areas of responsibility include, but are not limited to:
* Black Utilities: Instrument Air Generation and Distribution, Black Steam Reduction and Distribution Systems, Chilled and Cooling Water Generation and Distribution Systems, Cooling Towers, Sanitary Systems, Drinking/Heating Water Systems, etc.
* Clean Utilities: Compressed Air, Nitrogen, Softened Water, Purified Water System, Clean Steam Generation and Distribution, WFI Generation and Distribution.
* HVAC Systems
* Execute and review Commissioning and Qualification test protocols (using the KNEAT electronic documentation system), including:
* Sequence of operation testing (start-up, hold, abort, stop, emergency stop sequences)
* Control loop tuning
* Pump and fan testing
* Alarm and interlock testing
* Troubleshoot and resolve mechanical and electrical issues identified during commissioning, ensuring proactive issue escalation.
* Support integrated commissioning of DeltaV system software, hardware, and interfaces with listed process and utility systems.
* Provide hands-on engineering support to ensure reliable operation of automated systems, addressing control system and process issues.
* Fine-tune equipment performance to meet required acceptance criteria.
* Ensure correct and safe start-up of black, clean utilities and HVAC systems, taking into account the risks and mitigations detailed in RAMS (Risk Assessments and Method Statements).
* Support or lead other CQV activities if needed.
* Ensure CQV field execution is performed safely and in accordance with my client's HSE standards. This includes Lock-Out-Tag-Out preparation and PSHR completion as system owner.
* Participate in shift work when required.
* Demonstrate a proactive approach to problem-solving.
* Maintain strong knowledge of interface management.
Candidate Profile:
Minimum Requirements:
* Bachelor’s degree in Life Sciences or Engineering
* Minimum 4 years of experience in process commissioning (required), with at least 3 years in utility system commissioning (preferred)
* At least 4 years of hands-on DeltaV DCS commissioning and troubleshooting experience, including the use of DeltaV Operate / Live and Control Studio
* Strong written and verbal communication skills in English
* Familiarity with applicable regulatory requirements and codes of practice for the Life Sciences industry
* Knowledge of cGMP and regulatory compliance
* Ability to work independently, managing deliverables to meet target deadlines
Preferred Requirements:
* Fluency in German is highly preferred
* Familiarity with my client's Commissioning/Qualification approach
* Experience with COMOS and KNEAT platforms
* Background in biopharmaceutical processes
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