Summary: Seeking a Manufacturing Engineer to support manufacturing operations, process optimization, equipment performance, troubleshooting, and continuous improvement in a regulated manufacturing environment.
Responsibilities: - Support daily manufacturing and production operations.
- Develop and optimize manufacturing processes for quality, efficiency, and cost.
- Troubleshoot equipment and process issues and perform root cause analysis.
- Support IQ/OQ/PQ, FAT/SAT, commissioning, and process validation activities.
- Manage/support deviations, CAPA, change controls, and non-conformances.
- Develop manufacturing procedures, work instructions, and engineering documentation.
- Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
- Support NPI, technology transfer, scale-up, and process improvement projects.
- Collaborate with Manufacturing, Quality, Validation, Engineering, and Supply Chain teams.
- Ensure compliance with GMP, FDA, ISO, and applicable regulatory requirements.
Requirements: - Bachelor's degree in Manufacturing, Mechanical, Industrial, Chemical Engineering, or related field.
- 3-7+ years of manufacturing engineering experience, preferably in pharma, biotech, medical device, or another regulated industry.
- Experience with process improvement, equipment troubleshooting, validation, and manufacturing documentation.
- Knowledge of GMP, FDA, ISO, CAPA, deviations, and change control.
- Strong analytical, problem-solving, communication, and project management skills.
Preferred: - Lean Six Sigma certification.
- Experience with GxP, IQ/OQ/PQ, CQV, FAT/SAT, MES, automation, or technology transfer.
