Advanced Manufacturing Tech Solutions · 5 hours ago
Senior Process Engineer (Pharma) - USA, North Carolina
North Carolina, United States
Full-time
Onsite
Senior Level
5+ years expAdvanced Manufacturing Tech Solutions is a leader in Life Science Manufacturing Technology solutions, seeking a Senior Process Engineer to support GMP manufacturing operations. The role involves overseeing process systems, ensuring performance, and driving continuous improvement in a regulated pharmaceutical environment.
Pharmaceuticals
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
Qualification
Required
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
Company
Advanced Manufacturing Tech Solutions
We are Delivering Innovation through Technology for Life Science Manufacturing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase