Senior Process Engineer - Containment

Job Responsibilities:

• 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.

Job Qualifications:

• BS or higher in Engineering or related technical discipline.
• 7+ 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.