Bioprocess Engineer

Revance • Newark, CA

11h • Onsite

About The Position

The Bioprocess Engineer will support GMP DS manufacturing operations by providing process development, equipment improvement, technology transfer, data analysis, and engineering oversight. Represent DS in cross functional efforts including equipment validation, regulatory submissions, regulatory agency inspections, and systems compliance. Utilizes technical and process expertise to provide training, troubleshooting, process trending, and hands on execution of cGMP production.

Requirements

• Bachelor's degree in biological sciences, chemical engineering or related discipline or equivalent professional experience.
• 5 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
• Advanced experience in a cGMP environment, and a comprehensive understanding of cGMP operations and documentation.
• Intermediate experience with fermenters at 100L scale or greater, or with UF/DF and chromatography equipment. Includes understanding of equipment operation, subcomponent function, and process design.

Nice To Haves

• Advanced experience with process development, transfer, and optimization a plus.
• Advanced experience with execution of validation protocols a plus.
• Advanced experience working with potent/toxic agents a plus
• Intermediate experience with authoring and review of regulatory submissions a plus
• Experience with JMP, SAS, or R software

Responsibilities

• Ensure manufacturing equipment is fully operational and optimized or modified for complex GMP productions.
• Write and review Manufacturing documents such as SOP's, batch records, change controls, and technical reports
• Lead investigations, root cause analysis, writing of deviation reports, change controls, and corrective actions
• Serve as SME in extractables and leachables (E&L), Data Historian, regulatory submissions and facility inspections
• Maintain manufacturing database and perform data analysis
• Provide technical support and guidance for design, development, transfer and implementation of new upstream and downstream processes or process improvements in Manufacturing
• Execute start-up and documentation of new process equipment validation, including factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Provide technical oversight to team in regular day-to-day requirements to execute full cycle of Manufacturing Drug Substance
• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) while ensuring compliance with established internal control procedures.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Generous Paid Time Off, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level