A client of mine is looking for a CQV Lead/SME for a project in Munich, details are as follows:
Role Description:
• Join a diverse team from various fields (in a seconded client position) responsible for overseeing Commissioning & Qualification (C&Q) operations at a large Animal Health facility, overseeing the work of our C&Q partner/engineers on site.
• The ideal candidate should have a proven track record in successfully managing systems from the Design Phase to Construction Handover, while navigating the Commissioning and Validation process to ensure a smooth transition to the Manufacturing phase.
• Strong communication skills and the ability to inspire others are essential for this role, as the candidate will be leading a team of Commissioning and Qualification engineers.
• The candidate will collaborate closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT, and QA.
• It is preferred that the candidate has knowledge of digital execution methods (such as KNEAT) for the digital implementation of C&Q lifecycle deliverables.
Role Function:
• Provide regular updates and collaborate with the Project C&Q Lead.
• Facilitate and organize a commissioning and qualification program for the Clean/Black Utilities Suite Team.
• Support the Suite Team Lead in planning and tracking activities, in close coordination with the assigned C&Q partner.
• Maintain effective communication channels among all stakeholders on the C&Q team and the overall project to ensure clear understanding and collaboration.
• Participate in GMP design reviews, including DQ and CLIA, as necessary.
• Review and contribute to deliverables such as technical requirement specifications and vendor turnover documentation.
• Implement the C&Q Strategy and associated deliverables, including System Level Impact Assessments, Component Level Impact Assessments, System Boundary Drawings, and Requirement Traceability Matrix.
• Oversee the creation, execution, and approval of C&Q documentation in electronic format using KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) based on approved client templates and design documentation.
• Review Change Control Requests (CCRs) and Test Operating Procedures (TOPs), which may involve travel to vendor shops and regular communication to ensure compliance with documentation requirements outlined in Vendor Documentation Requirements (VDRs).
Skills/Knowledge:
• Possessing knowledge and familiarity with process control systems and automation, with valuable experience in Siemens PCS7.
• Demonstrating a proficient understanding of the documentation requirements for C&Q in relation to cGMP process equipment and utilities.
• Utilizing digital execution methods, such as PIMS and KNEAT, to effectively implement C&Q deliverables in a digital format.
• Fluent in written and verbal English communication, enabling effective interaction.
• Capable of comprehending project plans and schedules to ensure successful project management.
• Proficient in using word processing, spreadsheets, database management software, CAD software, and PCs.
• Skilled in the development, initiation, selection, coordination, and management of projects, with a problem-solving mindset for unique challenges.
• Knowledgeable about regulations and standards relevant to medical devices, biologics, and pharmaceutical products.
• Well-informed about the latest industry standards and guidelines concerning C&Q, including ISPE/ASTM.
• Possessing strong interpersonal and communication skills, both orally and in written form.
Requirements:
• Possess a Bachelor's degree in Engineering or a Science-related discipline in the field of Engineering or Technology.
• Accumulate at least 8 years of experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within the Animal Health/Biotech/Pharmaceutical industry.
• Demonstrate technical proficiency in utilities, filling and formulation equipment, biotechnology processes, and preferably, a comprehensive understanding of FDA and EU regulations.
• Exhibit a minimum of 5 years of experience in supervisory positions, project management, and budget management.
• EU passport
