Sr. Process Engineer

Overview

Senior Process Engineer – Upstream (Holly Springs, NC). Responsibilities span equipment ownership for project execution, design, FAT/SAT, commissioning, qualification, and turnover. The role includes process, equipment, and facility changes in a cGMP environment, coupled with technical SME support to cross-functional teams for large facility projects.

• Serve as equipment owner for project execution including process and facilities design, FAT, startup, SAT, commissioning, and qualification.
• Execute process, equipment, and facility changes in a cGMP environment.
• Provide Subject Matter Expert (SME) level technical support to Engineering Design, Construction Management, and CQV/Start-up teams for large facility projects.
• Be accountable for downstream process equipment including supporting and troubleshooting process-related issues and deviations.
• Optimize equipment operations and maintenance to achieve yearly reductions in operating costs.
• Identify and resolve safety hazards associated with equipment.
• Implement automated process improvements.
• Collaborate with cross-functional teams (Engineering, MS&T, Operations, Quality, Maintenance, EHS, etc.) during turnover, startup, and commissioning phases for facility, process, and utilities systems.
• Work with equipment designers and manufacturing offices to develop a cost-effective, working production process.
• Author project life-cycle documentation requirements for a cGMP-compliant project (URS, change management, system specifications, drawings, change control) and review documentation authored by Process Engineer level team members.
• Coordinate the selection and oversight of third-party engineering and design services through formal RFPs, competitive bidding, and objective, data-driven bid analyses.
• Author project specifications by studying product design, customer requirements, and performance standards; complete technical studies; prepare cost estimates.
• Develop, enhance, and implement systems that increase efficiency across all phases of service or production processes, from design to manufacturing.
• Serve as a technical expert and advise on corrections during investigations, identifying root causes and robust corrective actions for process and utility equipment/systems.
• Directly develop or oversee the development of engineering testing, commissioning, and process improvement projects to improve production capacity, quality, safety, and/or stability.
• Maintain safe work practices and include safety into design, including leadership in HazOP processes and enforcement of EHS policies.
• Lead FMEA and system- or process-specific safety evaluations such as pressure, chemical, or thermal analysis using data-driven tools to ensure operational safety.
• Mentor process engineer level system owners.

• Bachelor’s degree in Engineering (Chemical, Mechanical, or equivalent preferred).
• Minimum 8 years of relevant work experience within a cGMP regulated manufacturing environment including biotechnology.
• Previous experience as a system(s) owner from design phase through construction to turnover.
• Experience with facility design, process development, or equipment manufacturing within the biotechnology industry.
• Firsthand experience with process optimization in a highly automated environment.
• Good written and verbal communication skills.
• Proficient computer skills.
• Good analytical skills.
• Creative thinking and problem-solving skills.

• Hands-on experience with process equipment ownership (e.g., Chromatography, UF/DF membrane, CIP/SIP Skid, ultracentrifuge, buffer prep, or utilities).
• Some CAD experience (PFDs and P&IDs, Basic GAs, redline and update existing or create new).

Raleigh, NC (Holly Springs)

• Mid-Senior level

• Full-time

• Project Management, Design, and Engineering

• Design Services