CQ Utilities Commissioning Engineer
vor 3 Wochen
The Utilities Commissioning Engineer at Project Delivery Partners is responsible for supporting the successful execution of commissioning and qualification activities related to Utilities.
The Utilities Commissioning Engineer will work closely with the Client USER team, the CQ Area Owner, and other stakeholders to ensure adherence to the Baseline Schedule, functional, technical, and GDP compliance requirements.
Main Responsibilities:
- 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
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.
Requirements:
- 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
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