Role Summary
Operator - Manufacturing - Filling/Finish. The Aseptic-Isolator Operations team sterilizes, manufactures, and fills injectable parenteral products in state-of-the-art facilities to supply patients globally. This role involves working with advanced technologies on a global production line, learning transferable skills, and supporting current and upcoming products.
Responsibilities
- Operator Objectives: Ensure strict compliance with policies/procedures (Safety, Production Procedures, Sanitization, Gowning, etc.); complete training and qualifications to stay current and qualified to perform the job.
- Adhere to Parenteral Plant safety policies and procedures to contribute to a safe work environment.
- Perform sanitizations in classified areas to maintain sterility of the area, operation, and product.
- Adhere to standard operating procedures and current Good Manufacturing Practices to ensure product quality.
- Document process steps on appropriate batch documentation following Good Documentation Practices.
- Setup and perform operations in both aseptic and non-aseptic processes.
- Initial machine set-up.
- Machine changeovers.
- Initial troubleshooting.
- Basic machine adjustments and equipment cleaning (e.g., sensors).
- Component replacements, plug-and-play sensor replacements, equipment lubrication.
- Simple alignment checks.
Qualifications
- High school diploma/GED
- Completion of Post Offer Exam or completion of Work Simulation if applicable
- Authorized to be employed in the United States; no visa sponsorship anticipated
- Minimum 3 years manufacturing experience
Additional Preferences
- Technical Certificate
- Commitment to Team Success
- Commitment to Working Safely
- Demonstrated mechanical aptitude
- Attention to detail
- Basic math skills
- Basic computer skills with the ability to learn in more detail
- Excellent documentation skills
Additional Information
- Shift varies with areas to support 24x7 operations
- 8-hour days for training
- Transition to night shift: 12-hour nights (3-2-2-3) permanent shift
- Some overtime may be required
- Post-offer allergy test may be required for some products