Position Details

This role is an individual contributor role whereby the individual must be a self-starter with significant professional experience design, commissioning, qualification and continuous improvement of pharmaceutical facilities, utilities and equipment. 

Key Responsibilities:
•    Prepare, execute and report on CQV activities for assigned systems to include C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ and where applicable PQ activities.
•    Prepare, review and approve project documentation, ensuring technical accuracy and adherence to cGMP.
•    Support design reviews and system risk assessments with multiple stakeholders.
•    Confirm all vendor documentation executions are compliant with GxP practices and the executed documentation is acceptable to support CQV.
•    Complete field verifications during static and dynamic (functional) tests.
•    Participate in startup activities of energized equipment when necessary.
•    Interaction with vendors for project planning.
•    Perform system P&ID walkdown with construction prior to handover. Categorization of punch list items & tracking to completion.
•    Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
•    Confirm the site installation is as per approved design specification and meet system IQ requirements.
•    Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
•    Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
•    Manage project change and CQV discrepancies through close interaction with System User and Quality Assurance.
•    Support the handover of contractor and vendor systems to the user.
•    Ensuring that all vendors and sub-contractors assigned to the specific tasks are trained and have experience to carry out tasks.
•    Liaise with the various stakeholders on the Project team and the overall project to ensure clear communication between all parties.
•    Participation in and execute design reviews (DQ), when required.
•    Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
•    Manage the site attendance for the vendors, contractors and specialist contractors.
•    Liaising with Construction management team to ensure completion of mechanical completion packs, review of all contractors packs for traceability, review of all supporting vendor documents in timely manner to support execution.
•    Where necessary attendance at FAT’s at Vendor Sites anticipated to be in mainland Europe.

Job Specific Technical, Functional and Professional Competencies:
•    Strong understanding of GMP/GDP, regulatory and industry standards. 
•    Excellent verbal and written communication skills.
•    Ability to work effectively with Engineering, QA, Operations, Vendors and Project Managers. 
•    Strong attention to detail. 
Essential Education and Experience:
•    A minimum of an Honours degree in an Engineering or Science discipline
•    At least 3 years’ experience in the biotechnology and/or pharmaceutical industry, in a CQV role.
•    Proven experience in authoring, review and execution of CQV activities on a variety of Facility, Utility and Process Equipment is essential.

Desired Education and Experience:
•    Experience with clean utilities and aseptic processing facilities would be an advantage.
•    Experience in Computer Systems Validation is desirable.
•    Experience in temperature mapping of temperature control devices and sterilization cycles is desirable.