Process Engineer (Contract) Hudson WI
Overview
We seek an experienced Process Engineer to lead technical development and scaling of aseptic manufacturing processes for innovative pharmaceutical and combination-device products. This consulting engagement involves defining future-state aseptic operations by translating feasibility findings into robust process designs equipment requirements and contamination-control strategies. The role requires collaboration with technical stakeholders equipment vendors and project teams to ensure scalable compliant manufacturing aligned with industry best practices. Ideal for seasoned aseptic professionals who enjoy solving complex technical challenges and influencing critical design decisions.
What You'll Do11
- 1Lead technical efforts supporting aseptic process development equipment selection scale-up and qualification
- 2Translate feasibility study outcomes into practical process equipment and facility requirements
- 3Develop contamination-control strategies for aseptic assembly fill/finish and combination-product manufacturing
- 4Define and author User Requirement Specifications for aseptic processing equipment and controlled-environment workstations
- 5Evaluate specify and support implementation of Biological Safety Cabinets ISO 5 Grade A environments and related technologies
- 6Conduct risk assessments including process FMEA to identify risks and establish mitigation strategies
- 7Partner with equipment suppliers to evaluate decontamination sterilization and aseptic processing solutions
- 8Provide technical guidance during design reviews and stakeholder discussions
- 9Assess contamination risks environmental excursions and process vulnerabilities recommending effective controls
- 10Support handling transfer packaging and assembly controls for pre-sterilized components
- 11Assess contamination risks align strategies with EU GMP Annex 1 and industry best practices
Requirements11
- 1Significant experience supporting aseptic manufacturing fill/finish or combination-product manufacturing in regulated pharmaceutical biotechnology or medical device environments
- 2Hands-on experience developing processes from early-stage concept through qualification and validation
- 3Expertise with ISO 5 Grade A environments Biological Safety Cabinets or other controlled-environment systems
- 4Strong knowledge of contamination control principles and aseptic process design
- 5Demonstrated experience performing and leading risk assessments including pFMEA
- 6Experience collaborating with equipment vendors contract manufacturers and technical stakeholders
- 7Working knowledge of EU GMP Annex 1 requirements
- 8Ability to identify contamination risks and translate technical findings into practical solutions
- 9Preferred experience with aseptic fill/finish operations combination-product manufacturing novel decontamination technologies
- 10Experience conducting feasibility studies and translating findings into manufacturing strategies
- 11Experience supporting facility equipment or line design projects consulting subject matter expertise or technical leadership roles interacting with regulators auditors or customers
Salary Insight
$40 - $110k per year
Location
Required Skills
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