Aseptic Specialist I (1st Shift)

Role Summary

Aseptic Specialist I (1st Shift) for Michigan operations, performing setup, aseptic filling, inspection, lyophilization, capping, and cleaning in aseptic and non-aseptic environments within a lean manufacturing, safety-minded culture. Requires aseptic gowning certification and strong attention to detail, documentation practices, and collaboration within a high-performance team.

Responsibilities

• Perform setup, aseptic filling, inspection, lyophilization, capping, and cleaning operations in aseptic and non-aseptic environments.
• Maintain aseptic gowning certification and ensure compliance with manufacturing standards and regulatory requirements.
• Adhere to standard operating procedures and batch records; document activities accurately.

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 with experience using hand tools
• Required: Not allergic to Cephalosporin/Penicillin
• Preferred: Knowledge of cGMPs and production practices
• Preferred: Experience in Lean production and/or 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, PDCA, etc.)
• Preferred: Ability to train on area SOPs/OJT‚Äôs (equipment, process, paperwork)
• Preferred: Experience working with Tech Writer, creating and maintaining training documentation

Skills

• Basic math and reading comprehension
• Effective interpersonal communication
• Mechanical reasoning and troubleshooting
• Proficiency with Microsoft applications
• Attention to detail in a regulated manufacturing environment

Education

• High school diploma or GED

Additional Requirements

• Routine lifting of 20-50 lbs
• Prolonged periods of sitting and standing
• Ability to gown aseptically requiring frequent bending and balance
• Flexible hours; overtime may be required
• Manual dexterity to keep up with production pace
• Work environment may involve exposure to airborne particles (cephalosporin) and moving mechanical parts; PPE required
• 1st Shift: 5:30am - 2:00pm