Process Engineer – Manufacturing Operations
Job Description
We are seeking a Process Engineer to join our Manufacturing Operations team. This role focuses on process optimization, automation, continuous improvement, and cGMP compliance within a regulated environment.
You will work cross-functionally to improve manufacturing efficiency, reduce downtime, and ensure high-quality production standards.
Key Responsibilities
Process Engineering & Improvement
- Design, develop, and optimize manufacturing processes
- Analyze data, troubleshoot issues, and reduce downtime
- Implement automation and support process validation activities
- Manage timelines for equipment maintenance, repairs, and upgrades
Compliance & Quality
- Ensure adherence to cGMP and quality standards
- Maintain process documentation and support audits/investigations
- Conduct risk assessments and support NCR activities
Continuous Improvement
- Drive Lean Manufacturing initiatives to eliminate waste
- Perform root cause analysis (Five Whys, Fishbone, etc.)
- Track and improve OEE and performance metrics
Qualifications
- Bachelor’s Degree in Engineering, Engineering Technology, or Life Sciences
- 2–5 years of relevant experience
- Knowledge of GMP/cGMP and regulatory standards
- Strong analytical, problem-solving, and communication skills