My client a leading Pharmaceutical company now require a Process Engineer - Technology Transfer to join their rapidly expanding team.
The Process Engineer - Technology Transfer will play a key technical role in a new state of the art ATMP (Advanced Therapy Medicinal Product) facility.
This is a permanent role based in Dublin and it comes with a good salary and good benefits.
Responsibilities of Process Engineer - Technology Transfer
- Part of the cross-functional technology transfer team with the scope of regenerative medicine manufacturing
- Tracking activities on the Tech Transfer Schedule
- Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
- Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
- Planning, implementation and evaluation of experimental programs with regard to the manufacturing process incl. design of experiment, continuous process verification and process capability evaluation.
- Assist with the process validation and tech transfer runs.
- Support P3 operations team with achieving overall operational readiness schedule adherence.
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
- Accompany and supervise development, transfer, validation and process optimization operations in an aseptic manufacturing environment.
- Safeguard the timely and GMP compliant production of registration samples.
- Complete required documentation and change controls relating to technology transfer, development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.
Process Engineer - Technology Transfer
- At least 3 years’ experience in Pharma Manufacturing including technology transfer preferably in the biopharmaceutical / bioprocessing field.
- Detailed and in-depth knowledge of biopharmaceutical manufacturing operations, as well as Quality and Regulatory Affairs.
- Detailed knowledge in experimental design, statistical data analysis and quality by design
- Excellent trouble shooting and problem-solving skills
Follow us on Twitter, Facebook and LinkedIn
The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below