Process Engineer

Role Summary

As a Process Engineer, you will be a technical hands-on resource for the design, installation, qualification, operation, maintenance, and improvement of equipment and facilities located at the Upper Merion PSC BioPharma site as well as support for products manufactured at third party manufacturing sites.

Responsibilities

• Lead and/or participate in the design and installation of new, or modifications to existing, process or utility systems including upstream protein production systems (rocker bioreactors, bioreactors, centrifugation), downstream protein purification systems (chromatography, IDF, Viral Filtration, TFF), or utility systems to meet technical, budget, and schedule goals. Document modifications according to approved local procedures.
• Develop or review operation, safety and maintenance procedures for mechanical process and utility systems. Provide operational support to production and automation in a proactive hands-on manner.
• Troubleshoot and correct problems with process and utility systems using OE Tools and procedures.
• Provide maintenance support for existing process and utility systems. Analyze repairs and maintenance requirements to proactively address system weaknesses.
• In cooperation with the Validation Group, develop validation documentation including test protocols, and implement validation plans on new process and utility systems and changes to existing systems to maintain the validated status of existing systems.
• Develop training programs and provide training on process systems.
• Makes recommendations for improving existing systems that will reduce cost and improve system reliability.
• Stay current with developments in the field of BioPharma technology. Support the transfer of technology from development into manufacturing.
• Actively participate in the value stream team environment to ensure appropriate engineering input and integration of local and corporate engineering specifications

Qualifications

• Required: BS/BA in engineering or equivalent technical discipline such as a life science degree (chemical engineering preferred)
• Required: 1+ year with prior process engineering experience in the pharmaceutical industry
• Required: Familiarity with P&ID‚Äôs, equipment specifications, and plant operations
• Preferred: Familiar with cGMP‚Äôs and NIH Recombinant Guidelines for large scale biological processing.
• Preferred: Understanding of pharmaceutical industry and engineering practices.
• Preferred: Strong interpersonal skills; ability to work within a multi-disciplinary team; ability to generate options to resolve problems, prioritize solutions and implement decisions; strong communication skills with stakeholders across functions.
• Preferred: Project Lead, Project Management experience

Skills

• Process engineering
• Validation documentation and test protocols
• Maintenance and troubleshooting of process/utility systems
• Training program development
• Cross-functional collaboration

Education

• BS/BA in engineering or equivalent technical discipline (chemical engineering preferred)