Lead CQV Consultant

at  CONSULTYS

Missions
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.

Profil
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

Please refer the Job description for details