Process Technologist - Dermatology
An exciting opportunity has arisen for a Process Technologist to join the NPI-PT team at a world leading site. You will work as part of a team supporting the production area providing a technical service. This will involve provision of a troubleshooting service, working on technical projects and supply of technical data.
- Comply with all GMP guidelines and all Regulatory requirements, ensuring all documentation is of a standard acceptable to external inspectors (e.g. MHRA/).
- Undertake self-audits on a regular basis, to ensure implementation of the required technical and GMP standards is uniform throughout.
- Understands GPS / Lean principles and with support be able to use the tools and techniques as required.
- To lead small cross functional teams either for a small individual project or a sub-project.
- To have a direct line report to the relevant Team Manager and provide regular updates on all matters regarding the project.
- To act as a point contact and provide an effective troubleshooting service for the specific production areas of the Product Stream that have been allocated as the responsibility of the Technologist.
- All production, QA, engineering and operational planning staff working to be kept informed of identity of the troubleshooting point contact and the role being performed and any subsequent changes.
Skills and Requirements
- Understands the process validation lifecycle
- Uses product data for trending to support investigations and issue prevention
- Is able to identity and discuss potential for process optimisation and cost of waste reduction opportunities.
- Is aware that statistical experimental design techniques are available for process optimisation
- Plans and conducts/supervises manufacture/ filling or cleaning trials
- An ability to manage concurrent projects to tight timescales, both independently and in a cross-functional team environment.
- An enthusiastic approach to pharmaceutical process development and the ability to effectively communicate, both written and verbal, in a clear and accurate manner.
- Be able to author scientific technical documentation to the required standards with minimal rework
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.