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About the Role
The Process Engineer will manage multiple projects, develop procedures and systems to meet cGMP and operational efficiency requirements, and identify improvement opportunities within an FDA regulated environment. This hands-on role supports commercial manufacturing, R&D, and Validation operations, focusing on equipment and processes for aseptic manufacturing, inspection, and packaging.
Responsibilities
- Manage project timelines, documentation, procurement, implementation, and closure.
- Develop procedures and systems to meet cGMP and operational efficiency requirements.
- Identify opportunities for process improvement.
- Support commercial manufacturing, R&D, and Validation operations.
- Provide Subject Matter Expertise, chair meetings, and present topics to leadership.
- Communicate professionally with all levels of the organization.
- Assure compliance with cGMP requirements and adherence to SOPs.
- Create and manage project scope.
- Perform Factory Acceptance Testing (FAT) of manufacturing equipment.
- Improve operations for increased quality, productivity, efficiency, and cost savings.
- Investigate operational problems and recommend solutions.
- Identify ways to reduce production costs through recommendations.
- Evaluate the existing product portfolio to optimize profitability.
- Lead cross-functional value analysis teams to achieve savings goals.
- Provide key performance indicator data to improve processes.
- Support new production and development equipment through installation, commission, and qualification.
- Develop, implement, and improve maintenance practices and procedures with maintenance technicians.
- Identify, generate, and manage implementation of change controls.
- Collaborate with other departments to determine costs, run time, and cost reduction.
- Perform other tasks as assigned by management.
Requirements
- Ability to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Physically able to wear cleanroom/protective gowning and equipment.
- Able to occasionally lift and/or move up to 50 pounds.
Skills
- Project management
- cGMP compliance
- Technical documentation writing
- Computer assisted design software (MS Project/AutoCAD/Solidworks/Visio)
- Parenteral manufacturing equipment operation
Location
- Onsite
Work Type
- Full-time
Experience Level
- Minimum 3 years’ experience in a field related to manufacturing or industrial engineering
Education Level
- Bachelor’s degree in the sciences or engineering
- Manufacturing Engineering (ME) or Industrial Engineering (IE) degree preferred
- Lean Six Sigma certification preferred
Salary/Compensations
- $91,000 - $100,000
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
About the Company
- American Regent celebrates diversity and is committed to creating an inclusive environment for all employees.
Equal Opportunity
- We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
- Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf