Sr. MSAT Process Engineer Upstream

Role Title                    Sr. MSAT Process Engineer (Upstream)

Department                   MSAT

Supervisor                     Director of Manufacturing   

FLSA                               Exempt

CORE VALUES 

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY      Sr. MSAT Process Engineer (Upstream)   

The MSAT Senior Process Engineer (Upstream), under minimal supervision, is responsible for overseeing the development, transfer, validation, and troubleshooting of biopharmaceutical processes. The MSAT engineer is expected to serve as a Subject Matter Expert (SME) for a wide variety of process steps and equipment, with emphasis on Upstream manufacturing. Experience with process development, technology transfer, process validation, and cGMP biomanufacturing process is required. As part of the MSAT group, the Engineer must have a strong understanding of Upstream manufacturing processes to assist with process development and technology transfer. Ability to assist with/support routine manufacturing activities may be required.

Duties & Responsibilities:

1. Serve as the bioprocess Subject Matter Expert (SME) on multi-disciplinary project teams.
2. Use FMEA or other risk-based approaches to assess process performance.
3. Use Quality by Design (QbD) principles to design and execute scaled-down process experiments to increase process knowledge and prepare for process transfer/validation.
4. Perform process characterization studies using methods such as Design of Experiments (DOE).
5. Perform technology transfer of processes from small scale to clinical/commercial GMP scale.
6. Provide input into the design and procurement of process equipment, including development of URS documents and review of design documents.
7. Provide input into the validation of facilities, utilities, and equipment to ensure they meet the requirements of the process.
8. Oversee upstream process validation, including development of process validation protocols and reports.
9. Author, review, and execute FAT, SAT, IQ, OQ, and other commissioning/qualification protocols as necessary.
10. Assist with development and execution of the product changeover program.
11. Assist manufacturing management with development of production schedules, changeover schedules, or project schedules.
12. Participate in manufacturing activities as needed by the manufacturing department.
13. Create URS documents for manufacturing equipment based on process requirements.
14. Draft and execute PQ protocols for manufacturing equipment and utilities.
15. Interpret system performance data.
16. Review and draft risk assessment reports.
17. Perform GAP assessments related to the manufacturing process.
18. Provide technical assistance with Upstream manufacturing processes including E.coli fermentation, cell lysis, cell separation, media preparation, and filtration.
19. Don cleanroom attire such as coveralls, frocks, and boot covers and enter cleanroom areas as required.
20. Serve as the Upstream process SME in compliance audits.
21. Assist the production team with deviations, change controls, and process improvement activities.

Skills & Competencies

• Subject Matter Expert (SME) level understanding of Upstream cGMP recombinant protein manufacturing techniques, including fermentation/cell culture, cell separation, cell lysis, and media preparation.
• Familiarity with Downstream processing techniques such as column chromatography and TFF.
• Familiarity with analytical techniques used to evaluate the quality, identity, purity, and safety of biopharmaceutical products.
• Strong understanding of cGMP quality systems and documentation, including deviation investigation, change control, batch production records, and SOPs.
• Ability to gain knowledge of new processes quickly and understand how they can be implemented at a small or large scale.
• Experience designing and performing process development/characterization experiments, using either One Factor At a Time (OFAT) or Design of Experiments (DOE) approaches.
• Experience with data analysis using software such as JMP, Minitab, or Excel. Ability to communicate highly technical scientific data to a diverse audience.
• Ability to independently lead project initiatives related to process development, technology transfer, process validation, cleaning validation, or process improvement
• Ability to create and maintain strong working relationships with vendors to support the manufacturing process.
• Knowledge of facility, utility, and equipment validation procedures, such as IQ, OQ, and PQ.
• Knowledge of regulatory requirements for cGMP manufacturing of biopharmaceuticals.
• Strong technical writing skills.
• Good record keeping, organizational, written, and verbal communication skills.
• Knowledge of concepts of large-scale, automated production equipment, including: PLCs, P&IDs, Control Loops, Calibration, SCADA, PID Control, and Cascade Control.

Education & Experience

• B.S./B.A. in Engineering/Science Related Field. 8-12 years of relevant cGMP experience is desired.
• M.S. Degree in Engineering/Science Related Field.
• 5-9 years of relevant CGMP experience is desired.
• Ph.D. in Engineering/Science Related Field. 3-6 years of relevant cGMP experience is desired.