Hello,
My name is Bipasa, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Aseptic Process Engineer Sterilization process based in Hudson, WI (Hybrid) with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at [email protected]
Job Summary
We are seeking an experienced Aseptic Processing Engineer to support a prototype assembly project. The ideal candidate will have expertise in aseptic manufacturing, contamination control, and regulated manufacturing environments. This role focuses on defining processes, documenting technical requirements, performing risk assessments, and providing engineering recommendations to support process development.
Job Title: Aseptic Process Engineer Sterilization process
Location: Hudson, WI (Hybrid)
Key Responsibilities
- Develop contamination-control strategies for assembly processes.
- Define process, equipment, and controlled-environment requirements.
- Prepare process documentation, user requirements, control strategies, and risk assessments (pFMEA).
- Establish handling and transfer procedures for pre-sterilized components to minimize contamination and product damage.
- Evaluate process feasibility and recommend engineering improvements.
- Collaborate with cross-functional teams and external partners to support process development and implementation.
Required Qualifications
- Bachelor's degree in Engineering or a related technical field.
- Experience in aseptic processing, aseptic assembly, fill/finish operations, or regulated manufacturing environments.
- Strong knowledge of cleanroom operations, contamination control, environmental monitoring, Biological Safety Cabinets (BSC), and GMP practices.
- Experience with process risk assessments (pFMEA), technical documentation, and equipment/process requirement development.
- Understanding of microbiology, sterilization principles, particulate control, and contamination prevention.
- Strong analytical, problem-solving, communication, and technical documentation skills.
Preferred Qualifications
- Experience supporting process development, feasibility studies, or manufacturing process improvements.
- Background in pharmaceutical, biotechnology, medical device, or other regulated industries.
- Experience working with equipment suppliers and cross-functional engineering teams.
Bipasa Swain
Sourcing Specialist
7329976610 | Ext: 300
[email protected]
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