Technical Scientist/ Process Engineer is required for a global Biopharmaceutical company in Cork. The facility specialises in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials.
Excellent opportunity for a Technical Scientist/ Process Engineer to work in/as part of Technical Operations with responsibility for ensuring that internal and external manufacturing operations remain operational, continuously improve, and innovate.
The Technical Scientist/ Process Engineer will be responsible for:
- Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
- Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
The Technical Scientist/ Process Engineer requires:
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
- Minimum of 1+ years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
- Experience in Fill Finish activities - (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
- Demonstrated ability to independently manage projects/work to schedule/deadlines such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Peter Cronin in LSC on 021 471 8208 to discuss this new Technical Scientist/ Process Engineer role in more detail or apply directly via this advert.