C&Q Lead Warehouse and Packaging

AMTSOL:

A leader in Life Sciences Manufacturing Technology solutions, AMTSOL partners with global pharmaceutical and biotechnology organizations to deliver Automation, MES, CSV, CQV, and Digital Transformation solutions across Singapore, Europe, and the USA.

Role: C&Q Lead Warehouse and Packaging

Role Scope:

• Specific Commissioning and Qualification Execution/Leadership experience for packaging equipment:
• Automatic packaging line with semi-automatic visual inspection booths and manual inspection booths
• Packing line including packing, labeling cartooning line and serialization system
• Additional C&Q experience for Warehouse Storage, Freezers, Cold Rooms and Freeze Thaw systems
• 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.