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.**
FAQs
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