Description
The successful candidate will be able to demonstrate a proven track record to lead C&Q project delivery efforts and to influence others, be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have technical knowledge of bio-pharma Cleanroom/HVAC/E&I, equipment and utilities systems.
Major/Key Accountabilities:
- Ensure there is a strong safety culture and performance in the execution of C&Q deliverables projects and that appropriate stage gate controls are in place prior to the commencement of C&Q activities.
- Coordinate a commissioning and qualification programme, incorporating utilities, cleanroom, upstream and downstream manufacturing equipment.
- Represent the Client and Coordinate the efforts of EPCM C&Q Team.
- Provide technical support to the EPCM commissioning team throughout the project life cycle.
- Assistance with management of changes in C&Q Phase with inputs to HAZOP and design reviews of proposed changes. Manage project changes and ensure all are captured, documented and assessed for Quality/Safety/Cost or schedule impacts.
- Attends field walk downs as client C&Q Representative to ensure that appropriate standards are being met with installations.
- Ensures that EPCM has appropriate stage gate approach in place to ensure rigour in allowing systems pass from Construction Completion to Energisation.
- Assist in the development of C&Q plans and successfully execute them according to established schedule, cost and performance standards.
- Attends and provides inputs to Interactive Pull Planning Workshops with stakeholders to plan out commissioning & qualification activities in a schedule critical project.
- Oversee via the EPCM the generation, execution and approval of Commissioning & Qualification documentation.
- Assist with the coordination of design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, internal personnel, outside contractors and vendors.
- Track and report C&Q progress as required against project deliverables.
- Third level degree in a relevant discipline.
- Proven level of experience in delivering Commissioning, Qualification & Validation (CQV) activities within the pharmaceutical sector.
- Experience of working in a project environment.
- Hands on attitude.
- Ability to sequence critical activities in planning work for C&Q Phase.
- Experience of CSV an Advantage.
- Some Knowledge of Temp Mapping an Advantage.
Must have as a minimum a 3rd level Degree.
Skills and Knowledge:
- A minimum of 8 years of relevant experience in capital projects preferably in Pharm/Bio Pharm.
- Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
- Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
- Strong interpersonal skills and an understanding of the customer/client relationship involved in projects.
- Excellent communication/presentation skills.
- Superior organisational and planning skills.
- Demonstrated achievements within multi-functional teams.