Lead CQV Consultant

• As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to:
• Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans.
• Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
• Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans.
• Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
• Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
• Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
• Guiding the C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.
• Lead the preparation activities for commissioning activities start-up.
• Coordination and interfacing with vendors for C&Q execution related activities. Also ensuring the execution is completed in accordance with CORP-35 principles.
• Guiding and overall oversight of the Commissioning field execution, including protocols execution. Coordinating the interface of test specifications
• 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 1 meetings, Wall meetings).
• Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
• Ensure discrepancies encountered are adequately reviewed and approved. Tracking of these deficiencies, including planning and executing the remediation actions
• Assist the C&Q Manager with the Handover and Release process.
• Leads the management of change for his area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner
• Supporting the commissioning field team with specific process tasks
• Ensures C&Q field execution is completed in a safely manner and following HSE standards.
• Liaising with Construction on design and construction issues.
• Participate in construction walk-downs and punch-listing 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.
• Support the C&Q execution team as Kneat Super User.

Your profile :

• University degree in Engineering, Chemistry or another relevant discipline
• At least 1 year of experience in Qualification and Validation of equipments
• Applied technical understanding of manufacturing or laboratory equipment; processes specific to Pharmaceutical manufacturing preferred
• Applied Knowledge of creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ)
• Analytical and structured working style; strong attention to detail
• Ability to effectively work as part of a multidisciplinary, international team
• Hands-on personality, with flexibility and dedication to maximize our client`s value
• Fluency in English is required, German or French would be a plus