Senior Aseptic Process Engineer

About the role

The Senior Aseptic Process Engineer will manage the engineering evaluation, vendor collaboration, feasibility assessments, and integration planning for aseptic process improvements. The role requires overseeing the implementation pathway for selected solutions derived from technical findings and prioritized opportunities.

Job Type: Contract | Location: Baltimore, MD | Application Deadline: Oct 12, 2026

Responsibilities

• Assess legacy aseptic filling and setup practices, including equipment and component level reviews such as open aseptic connections and sterile filtration assemblies.
• Translate contamination mechanisms and intervention-risk findings into engineering user requirements and design concepts.
• Lead technical evaluations of single-use bags, tubing assemblies, and closed-product-pathway options.
• Collaborate with vendors to identify solutions, conduct fit and compatibility reviews, and develop custom assemblies if necessary.
• Develop process flow diagrams, assembly drawings, and User Requirements Specifications for current and future states.
• Evaluate integration of proposed solutions into existing manufacturing workflows and equipment configurations.
• Assess compatibility and robustness of product-contact materials and processes.
• Develop and verify engineering studies and vendor demonstrations to ensure usability and reduction of open exposure.
• Partner with various departments to define impacts on change control, validation, and procedural practices.
• Prepare feasibility assessments, technical recommendations, and phased implementation roadmaps.
• Support procurement, design review, and installation activities, ensuring effective solution implementation.
• Provide technical ownership to confirm solution effectiveness and reduction of intervention frequency.

Skills

• Bachelor's degree in Chemical, Mechanical, Biochemical, Biomedical, Manufacturing, or related engineering discipline; advanced degree is a plus.
• Approximately 10+ years of experience in process engineering or related fields within sterile pharmaceutical or biologic manufacturing.
• Experience in improving or modernizing legacy aseptic filling operations.
• Direct experience with vial and/or syringe filling and sterile filtration.
• Practical understanding of first-air protection and contamination mechanisms.
• Experience with single-use bags, tubing manifolds, and aseptic connectors.
• Working knowledge of GMP engineering and design expectations.
• Ability to develop detailed engineering documentation.