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.
