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