17974-C&Q Lead-Carlow Contractor

This is a 24-month contract.

Purpose

• Be part of a multi-discipline team (in a seconded client role) responsible for Commissioning & Qualification (C&Q) activities on a large Drug Product facility, directing the activities of our C&Q partner on site.
• The successful candidate will be able to demonstrate a proven track record to take systems from the Design Phase through the Construction Handover stage and carry them through the Commissioning and Validation cycle to allow handover to Manufacturing.
• The candidate will be a convincing communicator with strong interpersonal skills to lead a team of Commissioning and Qualification engineers.
• This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT, and QA.
• This candidate will be required to have an understanding of digital execution methods (ie. KNEAT) for the digital execution of C&Q lifecycle deliverables.
• Report to the Global C&Q Lead for the company.
• Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
• Lead the planning and tracking of activities, working with the assigned C&Q partner.
• Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
• Participation in GMP design reviews (DQ, CLIA, etc), as required.
• Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
• Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
• Oversees the generation, execution, and approval of C&Q documentation in electronic format in KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
• Review of CCRs and TOPs. This may require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs.
• Report to the Global C&Q Lead for the company.
• Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
• Lead the planning and tracking of activities, working with the assigned C&Q partner.
• Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
• Participation in GMP design reviews (DQ, CLIA, etc), as required.
• Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
• Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
• Oversees the generation, execution, and approval of C&Q documentation in electronic format in KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
• Review of CCRs and TOPs. This may require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs.
• Generate C&Q change controls (FPIDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimized and closed out in a timely fashion.
• Responsibility for direct supervision of C&Q partner/suite team resources who are:
• Managing vendor engineers and contractors during C&Q activities.
• Managing the site attendance for the vendors, contractors and specialist contractors.
• Confirming all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
• Performing system P&ID walk down with construction prior to handover. Categorization of punch list items & tracking to completion.
• Supporting review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction, and Redlining exercises.
• Confirming the site installation is as per approved design specification and meeting system IQ requirements.
• Facilitating/expediting Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
• Generating method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
• Performing pre-start-up safety checks, LOTO & ensuring timely loop checking and calibrations.
• Coordinating and supervising third-party vendors during SAT execution. Reviewing and approving SAT protocols.
• Attending daily communication meetings with the suite team lead and reporting progress.
• Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
• Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations.

Responsibilities

• Implement Company GES C&Q strategies as aligned with the Global C&Q Lead.
• Ensure that system delivery progresses in accordance with the approved project schedule.
• Notify project management, in a timely manner, of all relevant issues which may impact system progress.
• Ability to work in design and construction project environments within Ireland.
• Coordinate with design and/or project teams to resolve any identified technical issues.
• Organize/attend all coordination meetings necessary to progress the job. Possess good communication skills.
• Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning, and contract team members are performed in accordance with site safe working practices.
• Ensure the cohesive operation of cross-functional teams and coordinate work for effective and efficient completion.

Requirements

• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
• Minimum of 8 years experience in commissioning and/or validation of Drug Products/Facilities/Utility systems within the Pharmaceutical industry.
• Technical knowledge of utilities, filling and formulation equipment, biotechnology processes, and a working knowledge of FDA and EU regulations is preferred.
• Minimum 5 years of experience with supervisory, project management, and budget management are required.
• Working knowledge of process control systems and automation. DeltaV experience beneficial.
• Advanced knowledge of C&Q documentation is required for cGMP process equipment and utilities.
• Experience using digital execution methods (ie. KNEAT) for digital execution of C&Q deliverables.
• Fluent in English, written and verbal.
• Ability to understand project plans and schedules.
• Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
• Skilled in the strategy development, initiation, selection, coordination, and management of projects and have the ability to solve unique problems.
• Knowledge of regulations and standards affecting devices, biologics, and pharma products.
• Knowledgeable with the latest industry standards and guidelines on C&Q, including ISPE/ASTM.
• Strong interpersonal and communication skills (verbal/written).