Production Engineer

Job Overview:
The Production Engineer will oversee daily production engineering operations to ensure safety, quality, and efficiency in a GMP-regulated manufacturing environment. This role involves monitoring and optimizing manufacturing processes, supporting equipment maintenance, and driving continuous improvements. The ideal candidate will contribute technical expertise to maintain regulatory compliance and enhance production performance while collaborating with cross-functional teams.

Job Responsibilities:

• Manage daily production engineering activities to ensure compliance with GMP requirements

• Monitor and optimize manufacturing processes to meet production schedules and performance goals

• Support equipment setup, calibration, and routine maintenance to ensure reliable operation

• Troubleshoot process and equipment issues and implement corrective and preventive actions

• Develop and maintain Standard Operating Procedures (SOPs) and work instructions for production

• Collaborate with Quality Assurance to ensure adherence to FDA, EMA, and other regulatory standards

• Participate in process validation, equipment qualification, and change control initiatives

• Lead root cause analysis and implement process improvements to improve product quality and throughput

• Coordinate with teams during new equipment installation and production line upgrades

• Maintain accurate documentation of production data, maintenance logs, and process deviations

• Support operator training and enforce safety and quality procedures

Qualifications:

• Bachelor’s degree in Mechanical, Chemical, Industrial, or related engineering field

• Minimum of 3 years experience in production or process engineering within a GMP-regulated manufacturing environment (pharmaceutical, biotech, or medical device preferred)

• Strong knowledge of GMP, cGMP, and applicable industry regulations

• Experience in process troubleshooting, equipment maintenance, and continuous improvement methods (Lean, Six Sigma preferred)

• Proficient in reading technical drawings, P&IDs, and equipment manuals

• Excellent problem-solving skills and ability to perform under tight production deadlines

• Strong written and verbal communication skills, with a demonstrated ability to work collaboratively across departments