CQV Utilities & Facilities/ Fill & Finish

We are looking to connect with talented CQV Engineers who have expertise in either Fill & Finish processes or Utilities & Facilities. If you have a strong background in commissioning, qualification, and validation, we want to hear from you!

Utilities:

• Main areas of responsibility includes, but is not limited to the following areas;
• 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 including the following test steps
• Sequence of operation testing including start up, hold, abort, stop and emergency stop sequences
• Control Loop Tuning
• Pump and fan testing
• Alarm and interlock testing
• Troubleshooting and finding resolutions to mechanical and electrical issues found during commissioning. Escalation of issues in a proactive manner
• Support the integrated commissioning of the DeltaV system software, hardware and interfaces to the various process and utility systems listed above
• Support the reliable operation of the various automated systems by providing hands on engineering support to troubleshoot control system process control and operational issues
• Fine tuning of equipment performance to meet required acceptance criteria
• Experience for correct and safe start-up of black, clean utilities and HVAC systems, considering the risks and mitigations outlines in method statements and risk assessments (RAMS)
• Shall be able to work / support another C&Q activity if deemed necessary
• Ensures C&Q field execution is completed in a safely manner and following HSE standards. This will include Lock-Out-Tag-Out preparation and PSHR completion as system owner
• Carry out shift work, where required
• Proactive in problem solving

Fill & Finish:

• Filling and semi-stoppering (filling, dose control, closing (stoppering), sampling and rejection of vials) using Peristaltic and Piston pump dosing systems for Lyophilized vials
• Filling Isolator (Internal environment Grade A (Iso 5), HVAC system, H2O2 decontamination process and Glove integrity tester, Rapid transfer ports for transfer of materials)
• Lyophilizers with mass spectrometer and dedicated loading and unloading isolator each
• ATEC Stopper treatment station and loading arm into the isolator

The tasks pertaining to this area are;

• Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans
• Overall planning and execution of the commissioning activities related to allocated areas or systems
• Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
• Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans
• Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
• Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
• Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)

Minimum Requirements:

• Bachelor's degree in Life Sciences or Engineering
• At least 4+ years of experience in process commissioning
• Fluent English language written and verbal communication skills

• cGMP knowledge and knowledge of regulatory requirements

Advantageous Experience:

• At least 4+ years of experience Delta V DCS hands on commissioning and troubleshooting experience
• Experience with COMOS/KNEAT platforms
• Fluent German language written and verbal communication skills

For further information about this position, please apply with your CV.

**Please note, only candidates who are authorised to work in Switzerland (e.g., Swiss nationals, EU/EFTA citizens, or individuals with a valid work permit) will be considered for this position.**