Job Summary:

The CQ Engineer is responsible to support KNEAT Doc PREP and Execution as it relates to CM oversight, MC acceptance, CQ execution and successful handover to the Client USER team. The scope of CQ activities will relate to Utilities. The CQ Engineer will report to the CQ Area Owner.

In line with PDP and Client C+Q requirements, the CQ Engineer will ensure adherence to the Baseline Schedule, Functional, Technical and GDP Compliance and adherence to Start Up safety procedures in line with best practices and Project expectations.

Main Responsibilities:

General Management and Coordination in conjunction with Client and PDP Team :

• Maintenance of training material and records

• Implementation of CORP-35 and supporting guidelines

• CQ Doc Preparation via KNEAT

• HSE and Safe Start-Up including PTW and LOTO

• CQV Execution Readiness

• CQV Execution via KNEAT

• MC, P+ID Walk down and Punch item Categorisation

• Deviation Management & Change Control (Process and Automation)

• Punch List Management

• Vendor Management

• System and Area Handover

Execution Readiness:

• FAT coordination as requested

• Documented training on PSPs

• CQ Team development and resource and allocation

• Monitoring and coordinate MC readiness

• CQV documentation readiness

• Monitoring and coordinate Automation readiness

• Monitor and coordinate SUT installation in conjunction with OPS/BPEs

• Calibration readiness including test equipment and resourcing

• HSE Plans, System PSSRs and LOTO device readiness

• Vendor notification of SAT dates per CQ Schedule

• Materials, consumables, spares, first fill available in stores

• Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution

CQV Execution:

• Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established

• Adherence to Client LOTOTO and PTW Systems

• MC acceptance

• CQ Execution (incl Coordination of E,I and C, Calibrations and Vendors)

• Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, CTOD and SAT)

• Tracking of changes, punch items and deficiencies

• Assisting system leads/engineers with system handover to production

Clean Utilities

• WFI Generation Systems

• WFI Storage Tanks

• WFI Distribution

• Clean Steam Generators

• Clean Steam Distribution

• O2/ CO2/ N2 Distribution

• Compressed Air (Oil Free) Distribution

Black Utilities

• Plant Steam Supply

• Plant Steam Condensate

• Process Drains

• Process Vents

• Process Waste Lift Station

• Chemical Waste Lift Station

• Protected (Potable) Fresh Water

• Safety Shower Water

• Utility Water

• Instrument Air

• Chilled Water (Supply/Return)

• Sanitary Waste & Vents

• Chemical Drains and Vents

• AC Collection Waste

• Fire Water Drainage

• Reference Air

Project Controls:

• Attend regular coordination meetings

• Liaise with CQ Area Owners w.r.t Plan and Progress Updates

Key Performance Indicators

• Strong knowledge and experience of Process Commissioning and Qualification.

• Management: Compliance with a 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.

Ideal Background:

• Education (minimum/desirable): Minimum BS in Engineering or Facility Management - preferably in Chemical, Mechanical, Facility, Industrial, Quality or Pharmaceutical Engineering.
• Languages: English - fluent in speaking and writing.
• Experience: Minimum 5 yrs. plus of Biotech or Pharmaceutical cGMP experience is required.
• Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
• Has successfully defended systems before FDA, EMA etc. inspections.
• CQV documentation experience Using KNEAT Software an advantage