Toms River, NJ 08753
The Process Mechanic performs activities including, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. The Process Mechanic will assess and consider the safety of our employees, the security of our assets and the quality of the services they deliver. This position will also coordinate outside contractors and vendors for various services. The Process Mechanic may also be required to perform facilities maintenance.
- Perform Line change over, set-up, start-up, including vision system training and data collection
- Employee will identify parts needed for repairs using parts manual for specific equipment, and will assemble requisition for supervisor to order parts.
- Responsible for on-going preventative maintenance of machinery or equipment
- Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. Also light facilities maintenance.
- Able to change over packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures
- Ability to be a team player; works cooperatively with others to solve problems and proactively helps others when assistance is needed.
- Experience in FDA regulated environment
- 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
- Able to Make effective decisions and take action based on deductive reasoning and potential product impact.
- Able to identify improvement opportunities in given processes / procedures
- Must possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means.
- Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
- Complete all required paperwork including FMS requests and MP-2 PMs.
- Must be able to be gowned qualified and maintain gowning status.
- 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.