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Senior/Principal MSAT Engineer
- Posted 03 October 2022
- LocationDurham
- Job type Permanent
- Reference68750
- Contact NameSam Heron
Job description
MSAT - Senior/Principal Engineer
BioTalent is supporting a Global CDMO with continued expansion, with some exciting new growth roles in the MSAT area.
The Senior/Principal engineer will be providing technical support for cGMP production runs, tech transfer activities, process engineering, process validation, process monitoring, and biopharmaceutical processes in the cGMP manufacturing facility.
Key Responsibilities:
- Support technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates, and define equipment selection
- Prepare/review technical documents, including supporting batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications
- Support technical deviation investigations and collaborate with Operations, Technical and Quality Management to determine event impact, perform root-cause analysis and corrective action identification
- Compile and analyze process data and communicate to client and upper management via production updates and campaign summary reports
- Supporting/leading collaboration on strategic projects or studies with external & internal partners and presents results in technical reports
- Present and defend procedures, validation and exceptions in audits and inspections
Key Requirements:
- Engineer III- BS in Science or Engineering with minimum of 7 years industry experience or Masters with 5 years industry experience or PhD with 3 years industry experience
- Previous experience working in a fast-paced manufacturing environment
- 3+ years cGMP experience
- Legal right to work in the US without Visa sponsorship
Please feel free to reach out to me directly or apply to this advert to learn more over a confidential call:
E: sam.heron@biotalent.com
T: +1 617 275 7696