Accountability Description

1. Responsible for creating accurate and timely cost estimates for projects in accordance with departmental procedures, to ensure that project proposals can be submitted for approval in line with the capital expenditure plan:

· Contribute to User Requirement Specifications

· Develop detailed technical specifications

· Generate tender documents for equipment procurement.

2. Lead complex engineering projects involving cross functional teams and multiple GMP disciplines (e.g. process / utilities / cleanrooms):

· Process Design

· Design Qualification, Design Review and HAZOP studies

· Process, equipment & component specification (plant, instrumentation, automation & consumables/disposables)

· Change control management

· Input into budget development and securing of Opex & Capex funding

· Automation approach including the Sequence of Operations and FDS definition

3. Budget and schedule responsibility for multi-disciplinary GMP projects, including monitoring and reporting on the status of major projects in multiple formats including board reports and presentations:

· Preparation and execution of equipment supply contracts

· Managing and supervising all consultant and contract staff undertaking project work.

· Discharge of CDM duties where appropriate.

4. Participate in the validation and handover processes for capital projects in liaison with quality assurance, production management and maintenance function, and ensure that all necessary training, drawings and documentation are provided for validation, operation and maintenance purposes.

5. Uphold and contribute to the development of site engineering standards to comply with regulatory and pharmaceutical industry requirements. Ensure that appropriate standards of GMP, housekeeping, safety and discipline are maintained at all times both within the department and operational areas.