What are the responsibilities and job description for the Aseptic Process Engineer - Sterilization process position at Intellectt INC?
Aseptic Processing Engineer
We are seeking an experienced Aseptic Processing Engineer to support an feasibility effort for a prototype clinical assembly line.
Key Responsibilities:
- Develop contamination-control strategies for prototype assembly processes
- Define aseptic process, equipment, and BSC (Biosafety Cabinet) requirements
- Author process requirements, control strategies, feasibility assessments, and pFMEAs
- Support risk assessments and engineering recommendations for prototype development
- Define handling and contamination-control requirements for pre-sterilized components
- Collaborate with equipment vendors and cross-functional technical teams
Required Experience:
- Hands-on experience in aseptic fill/finish, aseptic assembly, or combination-product manufacturing
- Experience in regulated pharmaceutical or medical device environments
- Strong knowledge of EU GMP Annex 1, ISO 5/Grade A environments, BSC operation, environmental monitoring, and contamination-control principles
- Experience developing engineering requirements, risk assessments, and technical documentation
Preferred:
- Understanding of microbiology, sterilization, bioburden, and contamination-control strategies
- Strong communication and documentation skills