Process Engineer

Job Summary:

The Sr. Process Engineer will lead the technology transfer process for drug substance manufacturing, 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 Cap Ex programs regarding new construction, equipment upgrades/retrofits/modernizations, and process improvements. May support drug product manufacturing as needed.

• Reporting to: Executive Director, MSAT & External Manufacturing
• Location: Newark | Onsite
• Salary Range: $120k - $145k + Bonus
  * The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location*

• Lead DSmanufacturingtechnology 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'sQuality 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,changecontrolsandinvestigationreports.
• Contributeassubjectmatterexpertduring
  
  CDC/FDA inspections.

EDUCATION:

Minimum

Required:

• B.S. in related Engineering or Physical/Life Science, preferably Chemical or Mechanical Engineering
• Prefer Six Sigma Black Belt

• 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.
• Preferred hands-on experience operating and troubleshooting:
  • Fer mentors/Bioreactors
  • TFF systems
  • Chromatography systems
  • Aseptics suites and biosafety cabinets
  • Automation 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.
• Experience with potent compounds or CDC Select Agent and Toxin regulations a plus.
• Must be familiar with the Microsoft Office suite of products.
• Aseptic filling experience and/or High Potent API experience a plus.

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

• 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!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.