Salas O'Brien
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. Responsibilities
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. Qualifications / Requirements
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. Desired Experience / 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). Location
Raleigh, NC (Holly Springs) Seniority level
Mid-Senior level Employment type
Full-time Job function
Project Management, Design, and Engineering Industries
Design Services
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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. Responsibilities
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. Qualifications / Requirements
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. Desired Experience / 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). Location
Raleigh, NC (Holly Springs) Seniority level
Mid-Senior level Employment type
Full-time Job function
Project Management, Design, and Engineering Industries
Design Services
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