Aseptic Fill Technician II – GMP Cleanroom Expert

United Pharma; Indiana; On-site; USD 34,000 - 48,000; Full time

Job summary

United Pharma in Indiana seeks a mid-level operator to support aseptic pharmaceutical manufacturing in a controlled GMP cleanroom environment. Isolator experience is preferred but not mandatory; strong manufacturing experience in pharma is required and food-industry experience does not qualify.

The role involves performing aseptic filling, equipment setup and sanitization, and ensuring compliance with SOPs, batch records, and GMP documentation.

Qualifications

• 3–5 years of aseptic filling experience in a cGMP pharmaceutical facility.
• Strong knowledge of GMP/cGMP compliance.
• Hands-on experience with aseptic filling, equipment cleaning, preparation, and assembly.
• Stopper preparation, capping, and packaging experience preferred.
• Ability to follow detailed SOPs and GMP documentation.

Responsibilities

• Perform aseptic filling operations using SOPs and batch records.
• Support cleanroom entry, sanitization, equipment setup, and supply replenishment.
• Perform component preparation, filling, capping, and related manufacturing activities.
• Operate and clean/prepare manufacturing equipment.
• Verify equipment calibration and maintain GMP compliance.
• Work independently with minimal supervision.
• Train new team members and provide floor leadership when needed.
• Follow safety procedures when handling/disposing of hazardous chemicals.
• Work with SIP100 and required PPE.

Skills

Aseptic filling

GMP/cGMP compliance

SOPs & batch records

Equipment cleaning & prep

Independent work

Job description

United Pharma in Indiana seeks a mid-level operator to support aseptic pharmaceutical manufacturing in a controlled GMP cleanroom environment. Isolator experience is preferred but not mandatory; strong manufacturing experience in pharma is required and food-industry experience does not qualify.

The role involves performing aseptic filling, equipment setup and sanitization, and ensuring compliance with SOPs, batch records, and GMP documentation.