Cqv Lead Consultant

Job description: - 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: - Preferably Bachelors level degree in Mechanical or Chemical Engineering. - Ability to work well under pressure and within strict deadlines - Minimum of 10 Years extensive experience in areas/systems under future responsibility. - Field CQV execution experience. - Considerable experience with cGMP - Strong interpersonal and communication skills. - Good Level in English, written and spoken / German a plus. - Experience in use of Kneat for documentation development and execution - Site presence 5 days/week Qui sommes nous ? Since 2005, the largest laboratories have renewed their trust in us. Specialized in pharmaceuticals, biotechnology and medical devices, we support our clients from R&D to the market launch of their products. Human-scale company, belonging to the Vulcain Engineering Group, we are committed to supporting and advancing our employees who are recognized for their technical and scientific expertise. Through our regional subsidiaries, we guarantee each one a geographical stability, without mobility clause on the main basins of activities in France, Belgium, Switzerland, Denmark and Canada. At Consultys, we prove that it is possible to combine Human and Performance. Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group’s success. Most of Consultys: - Stable, senior teams that accompany you in taking charge of your position - Tailor-made training tailored to your career prospects - The guarantee of working close to you, without geographical mobility