Manufacturing Technician III

Role Summary

Manufacturing Technician III reports to a Manufacturing Supervisor. In this role, you will execute all processes in production while strictly 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. In addition to making routine revisions to documents, you may rewrite complex procedures or initiate new procedures as applicable. You will have enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. You will have technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. This position is located in the Filling Department (C) working on a 2-2-3 rotating schedule with hours from 5:00 PM to 5:30 AM.

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 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, & 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 in addition to setting 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.)
• 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
• 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

Qualifications

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

Skills

• Proficiency in electronic systems such as EBM, JDE, etc.
• Strong problem-solving and troubleshooting abilities in manufacturing environments
• Ability to read, write, and follow detailed instructions in English
• Strong interpersonal and teamwork skills
• Understanding of cGMP regulations

Education

• High school diploma or GED; AA degree or higher with related work experience.

Additional Requirements

• 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; able to work 12-hour shifts (5:00 AM – 5:30 PM or 5:00 PM – 5:30 AM), in a 2-2-3 rotation
• Requires flexibility to work during off shift hours and/or support different shifts as needed
• Must be able to work overtime as required
• 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 8-12 hour shift
• Must be able to walk within and between quality rooms and packaging rooms, as well as throughout the 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
• Vision requirements: 20/20 near and distance vision with or without glasses and/or contacts (applies to visual inspection roles)
• Color vision considerations: may not be colorblind (applies to visual inspection roles)
• Work in a cold, wet environment
• Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection
• Indoor working conditions with exposure to loud noises requiring hearing protection
• Will work around moving equipment and machinery
• No makeup, jewelry, nail polish, or artificial nails may be worn in the manufacturing environment
• Work in a controlled environment requiring special safety gear or gowning; follow gowning requirements and wear protective clothing over head, face, hands, feet, and body (applies to Filling Department roles)
• May be required to work in confined spaces/areas
• Some Clean Room and/or cool/hot storage conditions (applies to Filling Department roles)
• May be exposed to cephalosporin; allergy risk for product-touch roles
• May require immunization before performing work within the manufacturing area