Senior Process Engineer - Containment
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-02-21
Listing for:
Harba Solutions Limited
Full Time
position Listed on 2026-02-21
Job specializations:
-
Engineering
Validation Engineer, Process Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
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.
- 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.
Position Requirements
10+ Years
work experience
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