Senior Black & Clean Utility Start Up Engineer

Project Delivery Partners GmbH
Visp

1W

Senior Black & Clean Utility Start Up Engineer

The successful candidate will manage the PDP Clean & Black Utility CQV team, including all deliverables for the new facilities and utilities scope of work based in Visp, Switzerland.

The function will be to plan, supervise and manage all works associated with all Clean & Black Utility CQV documentation (Using KNEAT software) walkdown, commissioning and qualification of the following systems:

  • General
    • BMS and Delta V Control
    • Gas Detection
    • LV Electrical Systems
    • Clean Rooms/ Architectural finishes
  • Start UP Safety
    • LOTO Management
    • PTW Implementation and Training
    • PSSR implementation and Training
  • 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
    • Process Air
    • Cooling Towers
  • Clean Utilities
    • PW Generation
    • PW Storage and Distribution Systems
    • WFI Generation Systems
    • WFI Storage Tanks
    • WFI Distribution
    • Clean Steam Generators
    • Clean Steam Distribution
    • O2/ CO2/ N2 Distribution
    • Compressed Air (Oil Free) Distribution
    • Supervising a team of engineers, operators and technicians in the following tasks:
      • Walk down of mechanically complete systems
      • Review of turnover binders from the various relevant contractors.
      • Execution of Design Qualification.
      • Execution of Installation Verification, which may be leveragable into IQ.
      • Execution of Installation Qualification which may be leveraged from IV.
      • Commissioning of systems including Troubleshooting
      • Execution of Operational Verification, which may be leveragable into IQ.
      • Execution of Operational Qualification which may be leveraged from IV.
      • Execution of Performance Qualification

Main responsibilities

  • Compliance with schedule including
    • Completion of tasks vs. schedule with daily meetings with staff to emphasise and communicate schedule targets, resolve issues, track progress and prioritise next actions.
    • Reporting progress for their area, with
      • Accurate status and % completion being reported on all tasks.
      • Schedule risks clearly identified as they arise.
      • Re-evaluation of time and personnel projected to complete work on a monthly basis to aid keeping live of schedule.
  • Identification and 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 all operator and technician and trade support.
    • Verifying document availability and timely signoff of all documents.
  • Fostering accountability in the team including measuring progress and earned value on an individual basis, and resolving any performance issues that arise
  • Technical stewardship including:
    • Helping team troubleshoot and resolve all issues.
    • Managing technical discussion on all deviations, changes, design issues and test failures.
    • Elevating to management any issues that cannot be resolved between the execution team and SME’s.
    • Quality Champion for their area including:
      • Ensuring documents are executed, filled in and controlled to a high standard.
      • Making sure that reviewer comments are promptly and effectively incorporated and that the performance of execution is continuously improved over the course of the project.
      • Communicating and leading compliance with all master plans and procedures.
      • Managing change control for their area to achieve the objectives of
        • SME and VRB (where needed) approval and consent to all changes.
        • 100% as-build design at the end of the project.
        • No test invalidated by change, and any repeat testing as a result of change identified and executed
  • Safety Champion for their area including:
    • Leading team in the preparation 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 supervised by appropriately trained, inducted and technically competent staff.
    • Leading team in understanding and following all procedures and policies.
    • Leading reporting and investigation into any safety incidents with Management and Safety group
  • Transition to operations Champion for their area including:
    • Facilitating operator and technician training for all equipment.
    • Making sure all manuals, spare parts and PM information is transmitted to operations group.
    • Effective use of the commissioning and qualification phase to integrate operators and technicians into the team to make sure that operations staff become familiar with the equipment.

Exclusions

Document preparation being completed by others.

Key Performance Indicators 

  • Experience: Strong knowledge and experience of Facilities and Utilities Commissioning and Qualification in a Biotech or Biologics Manufacturing environment.
  • Management: Compliance with schedule at a system and area level with the planned resource levels.
  • Safety: No lost time accident
  • Quality: Robust testing with minimum rework and re-execution
  • GDP: Exemplary documentation
  • SME – System Matter Expert for both Black & Clean Utility systems
  • Extensive CQV documentation experience using Digital CQV KNEAT Software
  • Extensive experience with the development of PSP’s
    • CTP Development and Execution
    • Permit To Work
    • LOTO
    • Change Management
    • Deviation Management
    • P+ID Management
    • Proficient in BMS and DCS-Delta V Automation Systems
    • Minimum 15 years of Pharmaceutical cGMP experience is required
    • Minimum of 20 years in Start up and Operational experience of Utilities
    • Has experience in leading a multidisciplinary engineering team
    • Schedule Management and progress measurement
    • Fluent in English
    • Certificate or Diploma in Engineering or Management
    • Certificate in Health and Safety
    • Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
    • Has successfully defended systems before an inspection auditor
    • Excellent technical writing skills
    • Expert in GDP – Good Documentation Practices

Background

  • SME – System Matter Expert for both Black & Clean Utility systems
  • Extensive CQV documentation experience using Digital CQV KNEAT Software
  • Extensive experience with the development of PSP’s
    • CTP Development and Execution
    • Permit To Work
    • LOTO
    • Change Management
    • Deviation Management
    • P+ID Management
  • Proficient in BMS and DCS-Delta V Automation Systems
  • Minimum 15 years of Pharmaceutical cGMP experience is required
  • Minimum of 20 years in Start up and Operational experience of Utilities
  • Has experience in leading a multidisciplinary engineering team
  • Schedule Management and progress measurement
  • Fluent in English
  • Certificate or Diploma in Engineering or Management
  • Certificate in Health and Safety
  • Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
  • Has successfully defended systems before an inspection auditor
  • Excellent technical writing skills
  • Expert in GDP – Good Documentation Practices