Commissioning and Qualification Lead

Roles Scope:

• HVAC and Clean Rooms: CQV engineer with leadership experience for HVAC, Clean rooms, LAFs, Isolators, etc. Development of associated C&Q strategies in accordance with regulatory and industry standards.

• Drug Linker: CQV engineer with leadership experience in Drug Linker and/or API facilities: C&Q experience shall include (but not limited to) reactors and purification suites, isolators, filter tryers, thermal oxidizers, solvent storage/handling, etc.

• Thermal Mapping: C&Q engineer with experience in development of temperature mapping strategies for (but not limited to) fridges, freezers, cold rooms, autoclave and warehouses, in accordance with validation and regulatory expectations. Role will require leadership and management of associated scope executed by client or third parties.

• Lab and Analytical: C&Q engineer (or equivalent) with QC background experience that allows leading as SME for validation via sampling/test method activities. The scope will involve identification and management of supporting third parties or internal resources that must support the testing scope.

Responsibilities:

As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks are (but not limited to):

• Ensure that CQV activities are executed in accordance with the Commissioning and Qualification Execution Plan and supporting Plans.

• Development of strategies and procedures that support their execution scope.

• Overall planning and execution of the commissioning activities related to allocated areas or systems.

• Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors

• Support development of C&Q schedule for associated scope.

• Coordinating the planning and scheduling of activities with supporting disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)

• Guiding C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.

• Lead preparation activities (e.g. start-up, procurement, vendors selection, etc)

• Coordination and interfacing with vendors for C&Q execution related activities.

• Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties

• Reporting of C&Q status, progress and issues during project stakeholders' meetings (e.g. Tier 2 meetings, Wall meetings).

• Review and approve CQV test scripts

• Ensure discrepancies encountered are adequately reviewed and approved in accordance with CQEP. Tracking of these deficiencies, including planning and executing the remediation actions

• Support the control of changes, ensuring cost, schedule and compliance are correctly assessed.

• C&Q execution milestones are completed as per baseline schedule

• Ensures C&Q field execution is completed in a safely manner and following Site EHS standards.

• Liaising with EPCM/Vendors on design and construction issues.

• Participate in construction walk-downs and snag list of these systems for Mechanical Completion.

• Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.
  

Job Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related discipline)

• Minimum of 10 years is preferable

• A relevant Third Level or Professional Qualification

• Familiar with methodologies related Risk Based Validation

• Field CQV execution experience.

• Considerable experience with cGMP

• Ability to work within strict deadlines

• Extensive experience in areas/systems under future responsibility.

• Strong interpersonal and communication skills.

• Good Level in English, written and spoken

• For Drug Linker: Knowledge of ATEX, process safety, and pharmaceutical engineering standards

• PMP (Project Management Professional) or equivalent certification

• Experience with high-containment or potent compound manufacturing facilities.