Lead Pharmaceutical Process Engineer
Leading a team of design and mechanical engineers, the individual will take a hands-on approach to pharmaceutical process engineering.
Setting strategies for addressing the engineering challenges of pharmaceutical process development and scale-up, the position holder is required to lead the development to commercial production of Midatech Pharma’s sustained delivery pipeline. This will involve novel engineering solutions, implementation of established solutions and industry best practice, and collaboration with external development partners.
Working at the interface between R&D and GMP manufacturing, the individual will be required to understand the chemical and pharmaceutical attributes of the products and ensure that the developed process can produce the volumes required whilst maintaining product quality and specification. The role transcends process development and in to technology transfer and validation, with involvement in making changes and improvements to manufacturing systems and controls, ensuring they are executed in compliance with cGMP. There is a requirement to support the engineering and manufacturing functions in the review and approval of validation documentation to meet cGMP requirements, specifically by providing expert support in risk management, protocol preparation and execution.
The role will further include management of resources, setting and adherence to budgets and regular reporting of progress to a multi-disciplinary management team. This role will be the technical authority on pharmaceutical engineering, combining excellent project management with hands-on, goal-focussed leadership of in-house and outsourced engineering resource.
As lead engineer the role includes mentoring and development of the engineering team. Working cross site to ensure changes, improvements and best practice are aligned across the UK and European sites, the opportunity exists for the successfully-led engineering function to address scale-up and pharmaceutical manufacturing challenges within the entire Midatech Pharma Group.
- Engineering degree
- 5-10 years’ experience of pharmaceutical/process engineering
- Working knowledge of CAD, CFD and related design support techniques
- Experience of GMP
- Thorough understanding of pharmaceutical process design and standards
- Excellent mathematical and analytical skills
- Understanding of pharmaceutical products and requirements for IMP and commercial manufacture
- Experience of project management to deadlines
- Knowledge of pharmaceutical equipment and process validation
- Experience of processing suspensions and powders
- Experience of managing multi-organisation grant-funded programmes
- Experience of handling pharmaceutical powders and suspensions
- Understanding of electronics and control systems
- Experience of aseptic manufacturing