Role Summary
The Manufacturing Technician III reports to a Manufacturing Supervisor. In this role, you will execute all processes in production following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the direction of the supervisor, you will oversee the hands-on execution of all activities in the production area. You may revise documents and may rewrite complex procedures or initiate new procedures as applicable. You will have applied technical knowledge to perform complex troubleshooting tasks and may assist during the transfer of new technologies into manufacturing, demonstrating leadership in cGMP compliance and EH&S skills. This position works 5:00am–5:30pm on a rotating 2-2-3 schedule.
Responsibilities
- Manage personal training plan to enhance knowledge, skills, and capabilities
- Troubleshoot process & equipment problems in a timely manner to minimize manufacturing downtime
- Conduct safety Gembas and provide coaching daily to ensure technicians adhere to proper ergonomic techniques
- Support all local manufacturing operations
- Operate general production equipment (such as filling, inspection, and packaging equipment)
- Complete relevant paperwork 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 and set up 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.
Qualifications
- High school diploma or GED; 4+ years of related work experience or AA degree or higher with 2+ years related work experience
- Must be able to speak, read, write, and follow detailed written and oral instructions in English
- Good interpersonal skills and ability to work effectively and efficiently in a team environment
- Understanding of cGMP regulations
- Familiarity with pharmaceutical production equipment including autoclave, DP oven and CIP/SIP
- Proficient in mathematics and able to work with metric and US measurement systems
- Knowledge of basic chemical and biological safety procedures
Skills
- Problem solving and troubleshooting
- Communication and collaboration
- Technical documentation and procedural writing
- Equipment operation and maintenance coordination
Education
- High school diploma or equivalent required; 2+ years related experience if AA degree or higher
Additional Requirements
- Work in controlled environments with gowning and protective clothing; may include hearing protection
- Remove makeup, jewelry, contact lenses, nail polish, and artificial nails in manufacturing areas
- Work in cold, wet environments and on multiple shifts, including weekends; possible 12-hour shifts
- Flexibility to support different shifts as needed; overtime may be required
- Ability to carry, lift, push/pull up to 30 lbs with assistance
- Stand/walk for extended periods and navigate between rooms and across the site
- May require bending, twisting, reaching overhead, squatting; repetitive motions may occur
- Vision requirements for visual inspection roles (20/20) and color vision considerations