Position Summary:
Responsible for setting up, operating, troubleshooting, and maintaining production filling and support equipment. Ensures assembly and testing of manufactured goods to guarantee product functionality and quality.
Key Responsibilities:
- Set up, operate, troubleshoot, and perform preventive maintenance on solution filling lines, vial cappers, and tray loading lines.
- Conduct fill weight checks, oxygen in headspace analysis, and bottle torque checks on filled product containers.
- Perform sterile solution filtration processes.
- Unload sterilized equipment from autoclaves and depyrogenated glassware from ovens.
- Operate autoclaves for sterilization of equipment and terminal sterilization of products.
- Operate vial and ampoule washers, in conjunction with dry heat ovens, to prepare components for aseptic processing.
- Clean and prepare filling equipment for multiple operations.
- Complete batch record documentation and review applicable Standard Operating Procedures (SOPs).
- Maintain a clean and sanitary work environment.
- Participate in pre-FAT testing for new production equipment, which may require travel.
- Support new equipment validation efforts.
- Perform supervisory duties in the absence of supervisors or during second shift operations.
- Train new employees on all job duties.
Qualifications:
- High school diploma or General Education Degree (GED).
- Minimum of two (2) years of related pharmaceutical experience and/or training, or an equivalent combination of education and experience.
- Demonstrated mechanical aptitude in the setup and maintenance of pharmaceutical manufacturing equipment.
- Ability to meet attendance standards and work a 40-hour week; certification to work in cleanrooms for aseptic filling.
- Ability to stand, walk, stoop, kneel, or crouch for extended periods; regularly lift objects up to 10 lbs.; push carts weighing 500 to 1000 lbs.; lift baskets with products weighing 10-20 lbs.
Work Environment:
- Exposure to moving mechanical parts.
- Handling of products or substances that are caustic, carcinogenic, and/or flammable; proper safety equipment is provided and must be worn.
- Use of open flames in the ampul sealing process; care must be taken to avoid exposing flammable liquids or substances in the vicinity.
- Working conditions may include wet, humid, or dry, cool environments.
- Exposure to steam, hot containers or equipment, and hot Water for Injection (WFI) up to 121°C; proper safety equipment is provided and must be worn.
- Exposure to dry heat ovens at temperatures up to 265°C; proper safety equipment is provided and must be worn.
Job Type: Full-time
Pay: $26.00 per hour
Benefits:
- 401(k) 4% Match
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 5x8
- Monday to Friday
Education:
- High school or equivalent (Required)
Experience:
- related pharmaceutical and/or training: 2 years (Required)
Ability to Commute:
- Decatur, IL 62522 (Required)
Work Location: In person