Senior Process Engineer; Pharma North Carolina
Job in
Greensboro, Guilford County, North Carolina, 27497, USA
Listed on 2026-02-12
Listing for:
Advanced Manufacturing Tech Solutions
Full Time
position Listed on 2026-02-12
Job specializations:
-
Engineering
Process Engineer, Validation Engineer, Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Overview
A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Role - Senior Process Engineer (Pharma)
Location:
North Carolina, USA
This is a long-term, site-based position supporting GMP manufacturing operations. The role requires candidates to be based in North Carolina or willing to relocate to North Carolina to support on-site operational needs.
Responsibilities- Act as System Owner for upstream, downstream, or utility processes and equipment
- Monitor and trend critical process parameters (CPPs) and key performance indicators to ensure consistent process performance
- Support technology transfer activities from development to manufacturing and between sites
- Ensure effective contamination control strategies are implemented and maintained
- Drive yield optimization and process efficiency improvements
- Support capacity planning, debottlenecking, and long-term manufacturing strategies
- Manage process lifecycle activities including change control, continued process verification, and process improvements
- Ensure process safety through risk assessments, HAZOP participation, and mitigation strategies
- Support deviations, investigations, CAPA, and root cause analysis related to process performance
- Author, review, and approve GMP documentation including SOPs, batch records, and technical reports
- Act as SMEs during audits, inspections, and regulatory interactions
- Bachelors or Masters degree in Chemical, Biochemical, Biotechnology, or related Engineering discipline
- 5–10+ years of experience in upstream, downstream, or utility process engineering within pharma or biotech manufacturing
- Strong understanding of CPPs, CQAs, and GMP requirements
- Experience supporting technology transfer and scale-up activities
- Knowledge of contamination control principles and aseptic processing (where applicable)
- Experience with yield improvement, capacity planning, and lifecycle management
- Familiarity with process safety tools such as HAZOP, FMEA, or risk assessments
- Strong analytical, problem-solving, and stakeholder management skills
Position Requirements
10+ Years
work experience
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