Aseptic Specialist I (1st Shift)

Role Summary

Aseptic Specialist I (1st Shift) based in Michigan. Performs setup, aseptic filling, inspection, lyophilization, capping operations, and cleaning in aseptic and non-aseptic environments while adhering to regulatory and manufacturing standards.

Responsibilities

• Perform setup, aseptic filling, inspection, lyophilization, capping, and cleaning operations in both aseptic and non-aseptic environments.
• Maintain high attention to detail and communicate effectively within a high-performance team.
• Follow standardized procedures, batch records, and documentation practices in a lean manufacturing environment.
• Train and maintain aseptic gowning certification as required.

Qualifications

• Required: High school diploma or GED
• Required: Basic math, English communication skills, legible penmanship, reading comprehension
• Required: Ability to follow detailed instructions
• Required: Basic use of Microsoft applications and general computer skills
• Required: Effective interpersonal communication and a positive outlook
• Required: Mechanical reasoning and troubleshooting skills
• Required: Strong mechanical skills and experience with hand tools
• Required: Not allergic to Cephalosporin/Penicillin
• Preferred: Knowledge of cGMPs and production practices
• Preferred: Experience in Lean production/manufacturing environment
• Preferred: Previous aseptic experience, gowning certification, and knowledge of aseptic techniques
• Preferred: Reliable transportation and good attendance/time management
• Preferred: Experience in Lean Manufacturing and continuous improvement (5S, visual schedule, PDCA, M1)
• Preferred: Ability to train on area SOPs/OJTs – equipment, process, paperwork
• Preferred: Experience with Tech Writer, creating and maintaining training documentation

Skills

• Attention to detail
• Regulatory/compliance awareness
• Problem-solving and troubleshooting
• Effective communication
• Documentation and record-keeping

Education

• High School Diploma or GED

Additional Requirements

• Physical: Routine lifting of 20-50 lbs; prolonged sitting/standing; ability to gown aseptically requiring bending and balance
• Work environment: Exposure to airborne particles; PPE required; near moving mechanical parts
• Shift: 1st Shift (5:30am - 2:00pm); flexible hours and overtime may be required