Website Asset Recruitment
Commissioning and Qualification Lead
A superb career opportunity has arisen to join the project team of one of Irelands largest and most sophisticated vaccines fill-finish facilities. This site is a critical global market provider of commercial vaccines, biologics and small molecule drug products utilising cutting edge technology, equipment and facilities.
§ Operating in a seconded client role as part of a multi-discipline team responsible for Commissioning & Qualification activities on a large Drug Product facility, directing the activities of our clients C&Q partner on site.
§ The successful candidate will demonstrate a proven track record taking systems from Design through Construction to Handover stage and carrying through CQV cycle to allow handover to Manufacturing.
§ A CLEAR communicator, the selected candidate will have strong interpersonal skills leading a CQV team.
§ Demonstrable experience managing many stakeholders through periods of change in a project environment.
§ Tasked with introducing Digital Execution/One CQV/Productization to project and site teams.
§ Work closely with and coordinate between construction, Process, Technical Operations, IPT and QA.
§ Be required to have an understanding of KNEAT for digital execution of CQV lifecycle deliverables.
§ Report to the Global C&Q Lead.
§ Lead and coordinate a CQV program for Drug Product formulation and Filling, Clean and Black Utilities, Support Services, and Lab Equipment.
§ Lead the planning and tracking of activities, working with the assigned C&Q partner.
§ Liase 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. 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 minimised and closed out in a timely fashion.
§ Responsibility for direct supervision of C&Q partner / suite team resources who are:
o Managing vendor engineers and contractors during C&Q activities.
o Managing the site attendance for the vendors, contractors and specialist contractors.
o Confirming all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
o Performing system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
o Supporting review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
o Confirming the site installation is as per approved design specification and meeting system IQ requirements.
o Facilitating/expediting Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
o Generating method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
o Performing pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
o Coordinating and supervising third party vendors during SAT execution. Reviewing and approving SAT protocols.
o Attending daily communication meetings with suite team lead and reporting progress.
o Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
o Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations.
§ Implement client C&Q strategies as aligned with the Global C&Q Lead.
§ Ensure that system delivery progresses in accordance with the approved project schedule.
§ 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.
§ Notify project management, in a timely manner, of all relevant issues which may impact on system progress.
§ Ability to work in design and construction project environment within Ireland.
§ Coordinate with design and/or project teams to resolve any identified technical issues.
§ Organise/attend all coordination meetings necessary to progress the job. Possess good communication skills.
§ Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.
KNOWLEDGE AND SKILLS
§ Working knowledge of process control systems and automation. DeltaV experience beneficial.
§ Advanced knowledge of C&Q documentation 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 ability to solve unique problems.
§ Knowledge of regulations and standards affecting devices, biologics and pharma products.
§ Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.
§ Strong interpersonal and communication skills (verbal/written).
§ Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
§ Minimum of 8 years’ experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within 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.