About the Role
Supervising a team of CQ specialists, operators and technicians in the following tasks for each area:
Support FAT attendance and execution
Support on-site construction activities
Walk down of mechanically complete systems
Review of turnover binders from the various relevant contractors/suppliers.
Commissioning / functional testing of systems including Troubleshooting
Supporting IQ/OQ execution
Compliance with overall & CQ schedule including
Completion of tasks vs. schedule with daily meetings with team / resources to emphasise and communicate schedule targets, resolve issues, track progress and prioritise next actions.
Reporting progress for their area
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 SMEs.
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.
Organising and facilitating system training prior to handover.
System handover.
Requirements
Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.
Languages: English - fluent in speaking and writing.
Experience: Minimum 5+ yrs.
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
About the Company
Test Documentation Pre and Post Execution Approval
FAT - Oversight and responsibility to maximise leveraging
CM Oversight on physical installation and documentation with ultimate accountability for MC acceptance
Process Equipment (USP & DSP)
Process Support Equipment (Media, Buffer, CIP, Autoclaves & Washers)
Utilities - Clean & Black generation & distribution
Facility & HVAC Coordinate Process CQ activities with Facility lead
Commissioning - Management and Coordinate Commissioning execution team including but not limited to PDP CQ SME / Specialists, Vendors, Automation, Calibrations & Genentech FTEs.
Qualification Support with IQ and OQ requests and requirements.