Manufacturing Technician III

Role Summary

The Manufacturing Technician III reports to a Manufacturing Supervisor and executes production processes in a cGMP environment, following environmental health and safety guidelines and applicable regulations. You will oversee hands-on production activities, revise or write procedures as needed, and assist in the transfer of new technologies. You will lead production tasks with technical and administrative competence, contributing to efficient manufacturing of high-quality products.

Responsibilities

• Manage personal training plan to enhance knowledge, skills, and capabilities
• Troubleshoot process and equipment problems in a timely manner to minimize manufacturing downtime
• Conduct safety Gemba’s and provide coaching daily to ensure technicians are adhering to proper ergonomic techniques
• Support all local manufacturing operations
• Operate general production equipment (such as filling, inspection, and packaging equipment)
• Complete relevant paperwork and electronic system prompts/tasks, following GDP/GMP guidelines
• Manually clean all portable equipment and small parts
• Participate on Continuous Improvement Teams
• Receive and distribute supplies into the production area
• Ensure all components necessary for manufacturing are prepped and ready to meet schedule adherence, including setting up the next shift for success
• Assemble and operate manufacturing equipment
• Coordinate other groups such as maintenance/metrology to ensure preventative maintenance is done
• Demonstrate proficiency in electronic systems such as EBM, JDE, etc.
• Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor
• May perform other duties as assigned to enable team success and contribute toward professional development

Qualifications

• Have a good understanding of cGMP regulations
• Familiarity with pharmaceutical production equipment including autoclave, DP oven and CIP/SIP
• Proficient in different mathematical disciplines and be able to work with both the metric and USA standards of measurement
• Knowledge of basic chemical and biological safety procedures

Education

• High school diploma or GED. 4+ years of related work experience or AA degree or higher and 2+ years related work experience

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body; may include additional hearing protection for loud areas
• Remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment
• Work in a cold, wet environment
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
• Must be able to carry up to 30 lbs, lift up to 30 lbs, push/pull up to 30 lbs (with assistance of material handling equipment)
• Must be able to stand and/or walk for an extended period over an 8- to 12-hour shift between rooms and across the site
• Must be able to walk within and between quality rooms and packaging rooms, as well as throughout the entire plant
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks
• Repetitive motions with hands, wrists, turning head, bending at knees and waist
• 20/20 near and distance vision with or without glasses and/or contacts (applies to roles performing visual inspection only)
• May not be colorblind (applies to roles performing visual inspection only)
• May be required to work in confined spaces/areas
• Some clean room and/or cool/hot storage conditions (applies to roles in Filling Department only)
• May be exposed to and must not be allergic to cephalosporin (applies only to product touch roles)
• May require immunization before performing work within the manufacturing area
• Must be able to work on multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed
• Must be able to work non-traditional work hours, including weekends and holidays, as needed, and be able to work a 12-hour shift in a 2-2-3 rotation
• Requires flexibility to work during off-shift hours and/or conduct activities in support of different shifts as needed
• Must be able to work overtime as required