The role of the Manufacturing Engineer involves an array of responsibilities within the Manufacturing Department, including but not limited to supporting equipment deployment, maintenance, repair, technical documentation, and process enhancement for manufacturing operations.
Key Responsibilities
Monitor production to ensure compliance with cGMP, ISO, FDA, and OSHA standards.
Develop and update technical documents like Device History Records, Engineering Drawings, and Standard Operating Procedures.
Contribute to projects improving manufacturing efficiency, quality, and productivity.
Perform preventive maintenance and keep accurate maintenance records.
Assist with calibration activities and manage inventories for production equipment.
Facilitate production processes and identify equipment issues to prevent failures.
Support manufacturing tasks for Research and Development, including process validation.
Represent the Manufacturing Department in projects involving new equipment installation.
Additional Responsibilities
Participate in training, support QA investigations, collaborate on team objectives, and adhere to company policies.
Participate in audits as a Manufacturing Department representative.
Qualifications
Bachelor's degree in engineering or 4+ years of experience in a regulated industry.
Experience with equipment maintenance, strong communication, organizational skills, and proficiency in Microsoft Office.
Knowledge of cGMP, ISO standards, and TPM techniques is preferred.