Job Description
SRG are excited to be working with a global name in the healthcare industry to help them find a Bioprocess Engineer/Specialist within their Manufacturing, Science & Technology (MSAT) team.
This is a great opportunity for someone with strong GMP pharmaceutical manufacturing or process development experience who is ready for a new challenge.
This role offers flexi-time and excellent benefits such as private healthcare, enhanced pension and bonus scheme.
The Role:
* Prepare GMP batch records for use in manufacturing processes
* Review, approve, and issue manufacturing documentation
* Determine scale up criteria from development to manufacturing scale
* Generate process mass balances and flow diagrams
* Identify, design and define large scale manufacturing equipment
* Define materials for use in a GMP manufacturing environment
* Generate quality documentation for raw materials and equipment
* Work within the QMS and carry out investigations where required
* Implement CAPAs and change controls
* Project manage all aspects of the introduction of processes to manufacturing
* Perform risk assessments
* Evaluate process materials for suitability for use in manufacturing
Requirements:
* Degree in a relevant scientific or technical discipline and/or relevant industry experience
* Proven GMP pharmaceutical manufacturing or process development experience and technical knowledge and ability
* Experience of managing projects
* Prior experience of process scale up and technical transfer
* Good leadership and organisational skills
* Experience writing GMP batch records and documentation
* Ability to work in a fast paced environment