Director, Aseptic DP Process Engineering
Job in
Wilson, Wilson County, North Carolina, 27893, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering -
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
Job Description & How to Apply Below
Role:
Director of Aseptic Drug Product Process Engineering for a new biotherapeutics manufacturing facility at Johnson & Johnson, leading end-to-end process design and operational readiness.
Responsibilities:- Develop process specifications
- Assess vendor capabilities
- Troubleshoot during commissioning
- Coordinate across manufacturing, facilities, quality, and engineering teams
- Ensure compliance with cGMP, EHS, and regulatory standards (EU, FDA)
- Drive project execution, technical excellence, and team development, with a focus on facility design, process validation, and continuous improvement
- Minimum of a Bachelor's in Mechanical or Chemical Engineering
- 15+ years in biotherapeutic drug product process engineering within a cGMP environment
- At least 5 years in leadership roles
- Experience in capital projects (preferably $250-500M), greenfield site development, and facility start-up
- Deep knowledge of aseptic manufacturing standards, EU Annex 1, and regulatory requirements
- Skills include project management, vendor assessment, complex problem-solving, and cross-functional collaboration
High-value specifics: biologics, biotherapeutics, cGMP, aseptic manufacturing, facility design, commissioning & qualification, regulatory compliance, and international standards.
Location:Wilson, North Carolina, with >75% travel during project development.
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