Site Engineering Manager
The CQV Engineer will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment. This role will support both new and legacy equipment. This role is an individual contributor role whereby the individual must be a self-starter with significant professional experience in commissioning and qualification of Pharmaceutical facilities and Equipment.
- A minimum of a Honors degree in an Engineering or Science discipline
- At least 5 years' experience in the biotechnology and/or pharmaceutical industry, in a CQV role
- Proven Experience in execution of CQV activities on a variety of Facility, Utility and Equipment Systems
- Experience with clean utilities and aseptic processing facilities would be an advantage
- Experience in Computer Systems Validation is desirable
- Experience in authoring, review and execution of CQV studies and reports is a must.
- Proficient in written and spoken English.
- Prepare, execute and report on CQV documentation
- Complete field verifications during static and dynamic (functional) tests
- Participate in startup activities of energized equipment where necessary
- Interaction with vendors for project planning
- Reviewing and approving project documentation, ensuring technical accuracy and adherence to cGMP.
- 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).
- Attend daily communication meetings with suite team lead and report progress.
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Report progress to the Construction Project manager
- Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support CQV.
- 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
- As necessary attendance at FAT’s and ensure vendor audit actions are actioned
- Experience of Commissioning Qualification in a project environment.
- Experience in regulatory and industry standards for GMP and GDP
- Excellent technical writing skills including deviation reports and validation reports.
- Self Starter with time management and multi-tasking skills.
- Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail.
- Collaborative Team Player
- Excellent communication skills, both verbal & written.
- Adaptable and flexible, willing to travel when needed.