Perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance.
Responsibilities: • Perform Line change over, set-up, start-up, including vision system training and data collection • Identify parts needed for repairs using parts manual for specific equipment, and will assemble requisition for supervisor to order parts. • Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. • Maintain, repair and troubleshoot electronics on all production equipment on the sterile filling and packaging lines to minimize production downtime. • Use computer and logic controllers to perform system analysis of equipment. • Troubleshoot and repair PLC, VFD, Servos, temperature control loops, etc... • Troubleshoot vision systems and automated weight checkers • Fabricate and install simple control systems to enhance line performance. • Perform changeover of packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures. • Lead/Support small to medium sized process improvement projects to improve quality, safety and efficiency. • Ability to be a team player; works cooperatively with others to solve problems and proactively helps others when assistance is needed. • Shift flexibility per business needs, and willingness to work overtime • Demonstrated ability to be flexible and open to change, self-directed, motivated, and task oriented • Make effective decisions and take action based on deductive reasoning and potential product impact. • Identify improvement opportunities in given processes / procedures • Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means. • Must be able to gown to work in a clean room environment and maintain gowning status • Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation based systems. • Experience in a GMP or regulated environment
Qualifications:
High school degree, with a Minimum of 3 years of relevant mechanical experience; or equivalent combination of advanced education and experience. Experience in an aseptic/pharmaceutical packaging environment preferred.