Commissioning and Qualification Lead

ref. 01134

Commissioning and Qualification Lead

OPPORTUNITY

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.

JOB DESCRIPTION

§  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.

Functions

§  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.

DUTIES

§ 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).

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 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.