Job Summary
The CQ Engineer is responsible to support 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 PSP's
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/BPE's
Calibration readiness including test equipment and resourcing
HSE Plans, System PSSR's 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