Principal Engineer
Job in
Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-07-20
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-07-20
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Process Engineer, Manufacturing Engineer
Job Description & How to Apply Below
The Principal Process Engineer will provide technical leadership and process engineering support for automated inspection, device assembly, and packaging operations supporting pharmaceutical combination products, including prefilled syringes and autoinjectors. This role will be responsible for equipment onboarding, qualification, process validation, lifecycle management, and continuous improvement initiatives across inspection, assembly, labeling, cartoning, serialization, and packaging systems.
Essential Job Functions- Provide technical ownership and lifecycle support for automated inspection, device assembly, labeling, cartoning, serialization, and packaging equipment.
- Lead process engineering activities associated with onboarding new manufacturing equipment, including requirements definition, risk assessments, commissioning, qualification, and process validation.
- Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and startup activities for new manufacturing systems.
- Monitor and analyze manufacturing data to identify opportunities for process optimization, equipment performance improvements, and operational excellence initiatives.
- Lead investigations, troubleshooting efforts, and root cause analyses related to process, equipment, and product performance issues.
- Participate in process FMEAs and risk assessments to identify and mitigate process and product risks.
- Support implementation of new technologies, automation solutions, and continuous improvement initiatives within GMP manufacturing environments.
- Mentor and train junior engineers and manufacturing personnel on equipment operation, process performance, and engineering best practices.
- Interface directly with customers and equipment vendors to support project execution and technical deliverables.
Job Requirements
- Minimum 10+ years of experience in pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environments.
- Expertise supporting automated device assembly, packaging, and/or inspection systems within a pharmaceutical manufacturing environment.
- Experience with combination products, prefilled syringes, autoinjectors, medical devices, or pharmaceutical packaging operations.
- Hands‑on experience supporting equipment lifecycle activities, including commissioning, qualification, validation, FAT, and SAT.
- Bachelor's degree or higher in Engineering or related technical discipline.
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