Pharmaceutical Ops & Technology
Provide engineering support during the scope development of small and large capital projects.
Manage the design and the specification of new bioprocess equipment.
Provide support during the detail design and fabrication of equipment in order to maintain corporate equipment design standards in all capital projects.
Specify and implement modifications to improve operational performance and compliance in new and existing equipment.
Manage the evaluation and assessment of equipment vendors and equipment design to support the vendor selection and new equipment design.
Support site-engineering groups responding to process and equipment related issues during manufacturing campaigns.
Create and maintain relationships with the site engineering groups to develop and promote best practices in the design, fabrication and operation of bioprocess equipment.
Understands industry-wide and regulatory expectations of validation.Manage projects up to $1MM.
Manage engineering studies expense budget.
Experience in Biotech or Pharmaceutical cGMP processing.
Expertise in bioprocess equipment design, installation, and start-up.
Strong computer skills.
Knowledge of control systems and process instrumentation is a plus.
Experience with scale-up of biopharmaceutical production unit operations.
Experience with all of the following unit operations or technologies:
- Mammalian cell culture and bioreactor design
- CIP, SIP
- Cross-flow filtration
Demonstrated ability to work in cross-functional teams.
BS, MS in Chemical/Mechanical Engineering or Biochemical Engineering or related field with 8-10 years Biopharm experience.