Polaris Pharmaceuticals Inc. · 1 day ago
MSAT Process Engineer II – Upstream
Vacaville, CA
Full-time
Onsite
Mid Level
$110K/yr - $120K/yr
3+ years expPolaris Pharmaceuticals Inc. is seeking an MSAT Process Engineer II specializing in Upstream processes. This role involves overseeing the development, transfer, validation, and troubleshooting of biopharmaceutical processes, while serving as a Subject Matter Expert in the field.
Biotechnology
Responsibilities
Serve as the bioprocess Subject Matter Expert (SME) on multi-disciplinary project teams
Use FMEA or other risk-based approaches to assess process performance
Use Quality by Design (QbD) principles to design and execute scaled-down process experiments to increase process knowledge and prepare for process transfer/validation
Perform process characterization studies using methods such as Design of Experiments (DOE)
Perform technology transfer of processes from small scale to clinical/commercial GMP scale
Provide input into the design and procurement of process equipment, including development of URS documents and review of design documents
Provide input into the validation of facilities, utilities, and equipment to ensure they meet the requirements of the process
Oversee upstream process validation, including development of process validation protocols and reports
Author, review, and execute FAT, SAT, IQ, OQ, and other commissioning/qualification protocols as necessary
Assist manufacturing management with development of production schedules, changeover schedules, or project schedules
Participate in manufacturing activities as needed by the manufacturing department
Create URS documents for manufacturing equipment based on process requirements
Draft and execute PQ protocols and reports for manufacturing equipment and utilities
Interpret system performance data
Review and draft risk assessment reports
Perform GAP assessments related to the manufacturing process
Provide technical assistance with Upstream manufacturing processes including E.coli fermentation, cell lysis, cell separation, media preparation, and filtration
Don clean room attire such as coveralls, frocks,and boot covers and enter cleanroom areas as required
Serve as the Upstream process SME in compliance audits
Assist the production team with deviations, change controls, and process improvement activities
Qualification
Required
Experience with process development, technology transfer, process validation, and cGMP biomanufacturing process is required
Serve as the bioprocess Subject Matter Expert (SME) on multi-disciplinary project teams
Use FMEA or other risk-based approaches to assess process performance
Use Quality by Design (QbD) principles to design and execute scaled-down process experiments to increase process knowledge and prepare for process transfer/validation
Perform process characterization studies using methods such as Design of Experiments (DOE)
Perform technology transfer of processes from small scale to clinical/commercial GMP scale
Provide input into the design and procurement of process equipment, including development of URS documents and review of design documents
Provide input into the validation of facilities, utilities, and equipment to ensure they meet the requirements of the process
Oversee upstream process validation, including development of process validation protocols and reports
Author, review, and execute FAT, SAT, IQ, OQ, and other commissioning/qualification protocols as necessary
Assist manufacturing management with development of production schedules, changeover schedules, or project schedules
Participate in manufacturing activities as needed by the manufacturing department
Create URS documents for manufacturing equipment based on process requirements
Draft and execute PQ protocols and reports for manufacturing equipment and utilities
Interpret system performance data
Review and draft risk assessment reports
Perform GAP assessments related to the manufacturing process
Provide technical assistance with Upstream manufacturing processes including E.coli fermentation, cell lysis, cell separation, media preparation, and filtration
Don clean room attire such as coveralls, frocks, and boot covers and enter cleanroom areas as required
Serve as the Upstream process SME in compliance audits
Assist the production team with deviations, change controls, and process improvement activities
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
B.S./B.A. in Engineering/Science Related Field
3-5 years of relevant cGMP experience is desired
M.S. Degree in Engineering/Science Related Field
2-3 years of relevant CGMP experience is desired
Company
Polaris Pharmaceuticals Inc.
Polaris Pharmaceuticals, is a biopharmaceutical development and manufacturing organization (CDMO) specializing in biologics derived from microbial systems.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Hugh Yu
Chief Operating Officer
Company data provided by crunchbase