Process Engineer

Revance • Newark, CA

11h • $120,000 - $145,000 • Onsite

About The Position

The Process Engineer will lead the technology transfer process for drug substance manufacturing and will also work closely with the internal manufacturing team and provide support in the GMP manufacturing suite as needed.
The Sr./Process Engineer develops, establishes, and maintains quality-engineering methodologies, systems, and practices that meet internal and regulatory requirements. This position may also provide process engineering support for the Manufacturing and CapEx programs regarding new construction, equipment upgrades/retrofits/modernizations, and process improvements. May support drug product manufacturing as needed.

Requirements

• B.S. in related Engineering or Physical/Life Science, preferably Chemical or Mechanical Engineering
• 7 years minimum manufacturing, process development and/or engineering experience in a GMP/ GXP regulated environment.
• Must have working knowledge of biological processes and equipment.
• Must have excellent technical writing skills, and oral communication skills.
• May be required to wear personal protective equipment including respiratory protection equipment.
• Ability to work cross-functionally in a dynamic environment.
• Must be familiar with the Microsoft Office suite of products.

Nice To Haves

• Prefer Six Sigma Black Belt
• Preferred hands-on experience operating and troubleshooting: Fermentors/Bioreactors TFF systems Chromatography systems Aseptic suites and biosafety cabinets Automation equipment
• Experience with potent compounds or CDC Select Agent and Toxin regulations a plus.
• Aseptic filling experience and/or High Potent API experience a plus.

Responsibilities

• Lead DS manufacturing technology transfer by assessing novel equipment, workflows, analytical techniques, and process configurations
• Support manufacturing operations by incorporating equipment and process improvements within established processes, and by creating and/or revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Revance’s Quality System.
• Write technical protocols and reports, and contribute to global regulatory filings
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Provide statistical analysis and trends of the manufacturing process
• Authors deviations, change controls and investigation reports.
• Contribute as subject matter expert during CDC/FDA inspections.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, 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