Salas O'Brien · 4 hours ago
Sr. Process Engineer
Spring House, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSalas O'Brien is a company focused on engineering solutions, and they are seeking a Sr. Process Engineer to serve as the drug product system owner for project execution. The role involves overseeing process and facilities design, providing technical support, and collaborating with cross-functional teams in a cGMP environment.
Industrial EngineeringMechanical Engineering
Responsibilities
Serve as drug product system 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 as required for large facility projects
Collaborate with cross-functional teams (Engineering, MS&T, Operations, Quality, Maintenance, EHS, etc.) during the turnover, startup, and commissioning phases for facility, process, and utilities systems
Work with equipment designers and manufacturing offices to develop a cost-effective and working production process
Author project life-cycle documentation requirements as required for a cGMP compliant project (URS, change management, system specifications, drawings, change control, etc.) and review documentation authored by Process Engineer level team members
Coordinate the selection and oversight of third-party engineering and design services through authoring and initiating formal RFP documentation for competitive bidding and then execution of objective and data driven analysis documented in bid analysis forms
Author project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates
Develop, enhance, and implement systems that increase efficiency and optimize all phases of service or production processes, from design to manufacturing
Serve as a technical expert and advise on corrections during the investigation process, identifying root cause and robust corrective actions for process and utility equipment/systems
Directly develop or oversee the development of engineering testing, commissioning, and process improvement projects that 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
Mentoring for process engineer level system owners
Qualification
Required
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 drug product processing within the biotechnology industry
Firsthand experience with process automation in a highly automated environment
Good written and verbal communication skills
Proficient computer skills
Good analytical skills
Creative thinking and problem-solving skills
Ability to travel up to 50%
Preferred
Hands-on experience with process equipment ownership (Ex. Chromatography, adsorption, UF/DF membrane, CIP, ultracentrifuge, buffer prep, or utilities)
Some CAD experience (PFDs and P&IDs, Basic GAs, redline and update existing or create new)
Experience with Fillers and Isolators
Company
Salas O'Brien
Salas O'Brien is a national leading Facilities Planning, Commissioning, Construction Management and Mechanical, Electrical.
1001-5000 employees
H1B Sponsorship
Salas O'Brien has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (3)
2023 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Blackstone Group
2024-01-22Private Equity
Leadership Team
Paul Silva
Chief Operating Officer
Karl F. Frey
Retired
Recent News
Sports Business Journal
2025-10-24
FoodProcessing.com
2025-10-16
Company data provided by crunchbase