Senior Process Engineer (Pharma) - USA (North Carolina)

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: Indiana, 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.

Role Overview

The System Owner (Process Engineer) is responsible for overseeing assigned upstream, downstream, or utility systems within a GMP-regulated pharmaceutical or biotech manufacturing environment. The role focuses on monitoring critical process parameters (CPPs), ensuring robust process performance, supporting technology transfer, maintaining contamination control, and driving continuous improvement across yield, capacity, lifecycle management, and process safety.

Key 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 SME during audits, inspections, and regulatory interactions

Qualifications & Experience

• 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