CQV Engineer (German Speaking Essential)

Main responsibilities and tasks of the incumbent includes but are not limited to:

1. Attendance at Factory Acceptance Tests for key process equipment to witness and validate the
following:

• Compliance with URS, DQ and FAT protocols.
• Assess vendor compliance with applicable codes and standards.
• Raise punch items and sign off on FAT report.

2. Execution of Walk Down of mechanically complete (MC) systems including:

• Verification of installation in compliance with design and Client requirements.
• Identification of any technical issues as well as ergonomic or operational defects or clashes in the installation.
• Clear communication of defects and punchlist items to the Installation Contractor and/or vendor with follow up verification and approval of punch item close-out.
• Communication with Client Subject Matter Experts (SMEs) on the redline drawing, and technical issues arising from the walkdown.
• Verification of the as-build design documents.
• Witnessing of critical construction testing and IQ where relevant.

3. Execution of Installation Verification (IQ) including:

• Verification of documentation for critical elements of the system including Execution of Installation Verification including Drawings, Manuals, Preventive Maintenance, Spare / Change Parts and Lubricants.
• Verification of the installation of all Delta V components including instruments, panels, PLCs, I/O Cards, screens, servers etc.
• Verification (for critical components) of tagging, size/ range, material, installation and design compliance of all components including Instruments, Equipment, Piping, Valves/traps and other components.
• Verification of spare parts and preventative maintenance set-up.
• Follow the LOTO plan.
• Verification of installation/ construction testing and certification including pressure testing, cleaning/ passivation, calibration, loop checks, weld and material inspection and any other relevant construction quality documents.
• Raising of issues as they arise to the Client Subject Matter Experts.

4. Execution of Operational Verification (OQ) including:

• Verification of the operation of the equipment including all automated and manual functions.
• Functional Testing (Module Testing) of all CM's, EM's, Phases and Operations for Delta V systems.
• Operational Testing - Recipes and Unit Procedures.
• Raising of issues as they arise to the Client Subject Matter experts.
• Engage Vendor for CommSAT coordination.
• Coordinate First fill fluids (TCU's, CIP Skid cleaning chemicals, etc..)

5. Compliance with schedule including

• Completion of tasks in a timely fashion on or before scheduled date.
• Reporting progress of systems status and % completion.
• Identify schedule risks clearly as they arise.
• Early resolution of any and all schedule risks including:
  - Verifying all test pre-requisites are in place including personnel, materials, utilities, equipment and instruments.
  - Verifying that all vendor and trade support is well planned and managed.
  - Verifying document availability and timely signoff of all documents.

6. Safety Compliance including:

• Preparation/ review of effective risk assessments and method statements.
• Ensuring safe handover of systems with all LOTO, communication and training to make a safe and effective handover.
• Making sure all tests are well planned and executed safely.
• Understanding and following all Client procedures and policies.
• Reporting and investigation into any safety incidents with Management and Client Safety group.

Key Performance Indicators:

• Strong knowledge and experience of Commissioning and Qualification.
• Management: Compliance with schedule at a system and area level with the planned resource levels.
• Feedback from customer (i.e. Quality, HSE, operations)
• Safety: No lost time accident
• Quality: Well executed testing with minimum rework and re-execution.
• Quality: All deviations resolved to Client satisfaction and handover completed for all systems.

Qualification & Experience Requirements:

• Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science - preferably in Automation, Chemical, Mechanical or Pharmaceutical Engineering.
• Experience in Commissioning and Qualification of Clean Utilities and gasses.
• Experience in Commissioning and Qualification for the following equipment:
  - HVAC.
  - Buffer prep and hold
  - Single Use Mixers;
  - Tangential Flow Filtration;
  - Chromatography.
  - COTS (freezers, fridges, probes (pH and UV))
• Languages:
  - English - Essential fluent in speaking and writing.
  - German - Essential fluent in speaking and writing essential .
• Experience: Minimum 10 yrs.
• Broad knowledge of engineering disciplines, commissioning, compliance, qualification and validation.
• Excellent knowledge of Validation processes (IQ/OQ/PQ) and current regulatory requirements related to E2500 and ISPE 2004.
• Experience working within a GMP manufacturing environment.