- HND (or equivalent) in engineering or science discipline.
- Degree qualified in relevant engineering or science discipline.
- Working knowledge of clean room standards and medicinal product regulations.
- Good understanding of Laboratory and clean room processing equipment and facility services.
- Good knowledge of cGMP, MHRA/FDA regulatory requirements.
- Good Health & Safety knowledge.
- Recent extensive experience of working in a regulated environment in a broad engineering or technical capacity.
- New equipment introduction experience in a GMP environment.
- Generation of URS and other technical documentation.
- Change control management.
- Management of contractors.
- Broad experience of engineering and validation of pharmaceutical equipment, facilities, utilities, and control systems.
- Proven ability to deliver projects into production.
- General knowledge of building standards and planning regulations.
- Good Project management skills.
- Strong IT/Computer literacy skills.
- Good organisational and time management skills.
- Ability to communicate well across the business and build relationships with customers.
- Self-motivated, positive, enthusiastic, collaborative, and reliable.
- Methodical approach to problem solving, with excellent attention to detail, and the ability to apply fundamental Engineering principles to solve practical problems.
- Good presentation skills
- Project Management of new facilities and equipment introduction processes in a GMP environment.
- Provide expert advice and guidance on technical solutions for manufacturing process challenges.
- Generation of capital investment proposals including financial justification and
cost benefit analysis.
- Coordination of internal resources including Manufacturing, Quality
Assurance, Quality Control, Engineering, Validation, and Finance to generate user requirement specifications, manage change controls and ultimately drive
timely delivery of projects in line with business requirements.
- Coordination of external resources including suppliers and contractors.
- Generation of regular updates on progress of all ongoing projects for the Head of Engineering and Validation and the wider management team.
- Development of processes and procedures to streamline the introduction of