Sr. Process Engineer

Independently, the senior engineer performs discipline responsibilities within Project and Departmental budgets. Engineer is accountable technically and administratively to the Department Manager as well as Project Managers for successfully executing the Process group's work. Engineer is expected to serve in the roles of Project Discipline Lead and Engineer of Record. Engineer is expected to execute multiple projects of different sizes simultaneously.

Job Responsibilities include:

• Serve as robotics 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 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 officers 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.
• 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 junior staff.

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.
• Firsthand experience with process automation in a highly automated environment
• Experience with robotics/automated systems within the biotechnology industry
• 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 automation in a highly automated environment preferred (Emerson DeltaV, Siemens, Allen-Bradley).
• Some CAD experience (PFDs and P&IDs, Basic GAs, redline and update existing or create new).
• Experience with Fillers and Isolators

Location: Spring Holly, PA (Philadelphia area)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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