Technical Specialist - Manufacturing Process Development

We are currently looking for a Technical Specialist to join a leading Pharmaceutical company based in the Leicestershire area. As the Technical Specialist you will be responsible for delivery and implementation of lean manufacturing principles in Manufacturing Operations, training support, supporting technical investigations, and monitoring of the EMS and PW system.

Your duties as the Technical Specialist will be varied however the key duties and responsibilities are as follows:

1. As the Technical Specialist you will work with the Manufacturing Support and Operations Group to acquire knowledge and understanding of processes and technologies which are transferring to Development and Commercial Production.

2. You will support GMP Operations by providing technical input to resolve process challenges
and investigate or resolve Quality investigations.

3. As the Technical Specialist you will lead and deliver qualification of modifications or parts/components of process equipment, support the internal project teams with the selection of options and/or alternatives. You will technically support activities associated with technical transfer for new commercial processes on the site and associated documentation to support site registration, PPQ and future commercial production.

4. You will initiate, develop, maintain and audit 5S/housekeeping standards for the GMP Operations Facility to ensure a minimum standard suitable for reliable and robust operation.

To be successful in your application to this exciting opportunity as the Technical Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or technical discipline

2. Proven industry experience in the Pharmaceutical Manufacturing industry in an Operations Environment

3. A working knowledge and practical experience with technical transfer, scale-up, and process validation of equipment and processes. Experience in OSD (compression, capsule filling, stick pack) is desirable.

Key Words: Manufacturing, Process Development, Production, Pharmaceutical, GMP, Process Validation, Technical Specialist, Tablet, Capsule, OSD, Technical Transfer.