Job Description
Oversee, troubleshoot, and maintain mechanical systems and machinery used in pharmaceutical production, specifically sterile machinery, including ampoule and vial filling, packaging lines, autoclaves, inspection machines, and freeze dryers.
Provide technical leadership and support for the installation, calibration, and maintenance of sterile manufacturing equipment and machinery.
Ensure that mechanical equipment meets operational efficiency, safety, and compliance standards.
Perform preventative maintenance and emergency repairs to minimize downtime and optimize machine performance.
Ensure adherence to cGMP (current Good Manufacturing Practices) and company policies while working on all mechanical systems and equipment.
Assist in the setup, operation, and modification of machinery to meet production demands.
Collaborate with cross-functional teams to troubleshoot complex mechanical problems and provide solutions.
Ensure proper documentation for maintenance, repairs, and machine settings in compliance with regulatory requirements.
Provide training and technical support to junior engineers or technicians regarding equipment operation and troubleshooting.
Work on machinery used in non-sterile production lines such as liquid lines, semi-solids, nasals, and ophthalmic products.
Stay updated with the latest industry trends and innovations, recommending improvements to existing machinery or processes.
Bachelor’s degree or equivalent in Mechanical Engineering, Biomedical Engineering, or a related field.
6 - 10 years of experience with deep knowledge in sterile machinery and non-sterile machinery (such as liquid lines, semi-solids, nasals, ophthalmic products).
Experience working with non-sterile machinery (liquid lines, semi-solids, nasals, ophthalmic) is a plus
Advanced knowledge of cGMP and other pharmaceutical industry standards.
Problem-solving skills for troubleshooting complex mechanical issues.
Ability to work in high-pressure environments while ensuring safety and compliance.
Willingness to work extra hours or on night shifts when required to meet production needs.
