Senior Process Engineer
- Roseville, MN
- Permanent
- Full-time
- Write and execute qualification/validation protocols for processes and equipment used in pharmaceutical development and manufacturing.
- Perform Process qualification and validation for oral dosage forms (encapsulation).
- Oversee the training and transition of the production process to manufacturing.
- Assist Regulatory with submission documents. (Report writing)
- Optimization of powder characteristics, blending and blending validation.
- Support the refinement of oral formulation to provide a more concentrated and/or more stable product.
- Building deep technical knowledge regarding the manufacturing of finished product, intermediates, and components.
- Lead the development and validation of long-term GMP-compliant manufacturing processes.
- Provide direct technical support to ongoing oral dose manufacturing operations.
- Contribute to strategic planning for commercial volume manufacturing.
- Assist in selection and qualification of key suppliers and/or contract manufacturing partners.
- Write manufacturing documentation such as process work instructions, and procedures.
- Specify, procure, install, and qualify equipment.
- Create and maintain specification documents for materials used in manufacturing.
- Write and execute qualification/validation protocols for processes and equipment.
- Develop and improve manufacturing processes and related documents.
- Facility related design work, specifications, controls, maintenance and improvement.
- Cleaning validation.
- Willing to be on call approximately 6 times a year for 1 week each.
- Bachelor’s degree in Engineering or related field required.
- Master’s degree in Engineering or related field preferred.
- Minimum 10 years of manufacturing/process development engineering experience required.
- Minimum 10 years in the pharmaceutical or biopharmaceutical industry.
- High attention to detail.
- Investigation and CAPA experience.
- Spray drying experience preferred.
- Experience in structured problem solving and use of statistical tools.
- Experience in design for manufacturing DFMEA, PFMEA, DOE and Validations. Automation experience a plus.
- Experience with data-based decision making preferred.
- Ability to apply sound engineering logic to solve complex problems to properly assess risks and make decisions accordingly.
- Can work independently and in a team setting.
- Experience with biological manufacturing and encapsulation.
- Experience writing and executing qualification/validation protocols for processes and equipment used in pharmaceutical development and manufacturing.
- Experience specifying, procuring, installing, and qualifying equipment in development laboratories and/or manufacturing processes.
- Experience writing manufacturing documentation including process work instructions and procedures.
- Infrequent on call work
- Experience in bioprocess engineering with demonstrated experience supporting the development of an IND enabling process.
- Experience overseeing external contract organizations, and/or managing internal staff.
- Experience with spray drying.
- Microbiology experience is a plus.
- Direct to Sr. Manufacturing Engineering Manager – Engineering.
- Dotted line to Process Development Senor Scientist – Research & Development.