Sr. Process Engineer

Job Responsibilities include:

• 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.

Job 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 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%.

Desired Experience/Skills:

• 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

Location: Philadelphia, PA