Senior Process Engineer

Harba Solutions Inc. · Indiana, United States

This role will serve as a senior technical expert for containment systems and aseptic processing equipment, supporting isolators, barrier systems, and sterile manufacturing operations. You will lead process engineering activities, drive validation and lifecycle management for critical equipment, and partner cross-functionally to ensure robust, compliant manufacturing processes.

Requirements:

• Provide technical leadership for isolator and containment process engineering activities across sterile manufacturing.
• Assess and approve process and equipment changes, ensuring regulatory and quality compliance.
• Lead risk assessments, process FMEAs, and validation activities for aseptic and containment systems.
• Investigate and resolve process and equipment issues using structured root cause methodologies.
• Develop and execute engineering studies, process validation strategies, and technical documentation.
• Collaborate with automation, quality, manufacturing, and external vendors to support lifecycle management and continuous improvement.
• Mentor junior engineers and contribute to cross-functional technical teams.

Qualifications:

• BS or higher in Engineering or related technical discipline.
• 5+ years in a regulated manufacturing environment (biopharma, sterile injectables, or similar).
• Experience with aseptic processing, isolators, containment systems, or sterile manufacturing technologies.
• Strong technical writing, investigation, and cross-functional leadership skills.