Aseptic Filling Technician – GMP/Cleanroom Expert

Trident Consulting; Indianapolis (IN); Presencial; USD 77 366 000 - 85 962 000; Tempo integral

Resumo da oferta

Trident Consulting seeks an Aseptic Manufacturing Technician for our client in Indianapolis, IN. The role focuses on aseptic pharmaceutical manufacturing in a controlled cGMP/GMP cleanroom environment, with preference for isolator experience but not mandatory.

Pharmaceutical experience is required; food industry experience does not qualify. The position handles aseptic filling operations, equipment setup, and line support on 1st shift, with responsibilities including training, safety, and

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Aseptic filling experience

GMP / cGMP compliance

SOP adherence

Equipment cleaning & prep

Batch records / SOPs

PPE & safety

SIP100 familiarity

Ferramentas

SIP100

Descrição da oferta de emprego

Trident Consulting seeks an Aseptic Manufacturing Technician for our client in Indianapolis, IN. The role focuses on aseptic pharmaceutical manufacturing in a controlled cGMP/GMP cleanroom environment, with preference for isolator experience but not mandatory.

Pharmaceutical experience is required; food industry experience does not qualify. The position handles aseptic filling operations, equipment setup, and line support on 1st shift, with responsibilities including training, safety, and