A leading biopharmaceutical facility is seeking three Process Engineers to support downstream operations for a high-impact project. These roles will be instrumental in transitioning processing equipment from project completion into full operational readiness. The Process Engineers will collaborate across manufacturing operations, CQV, automation, and maintenance teams to ensure equipment ownership, process readiness, and operational excellence.

REQUIREMENTS FOR THE PROCESS ENGINEER INCLUDE:

• Minimum 5 years of hands-on experience with biologics processing equipment.
• Strong background in downstream operations (chromatography, UF/DF, buffer prep).
• Proven ability to work in fast-paced, execution-heavy environments.
• Must have biologics manufacturing experience—lab-only backgrounds will not be considered.
• Excellent communication and coordination skills across departments.
• Ability to take ownership of equipment and processes.

Downstream Process Execution & Support:

• Support startup and commissioning of downstream processing equipment including chromatography, UF/DF, and buffer preparation.
• Own equipment readiness and ensure seamless transition into GMP operations.
• Collaborate with cross-functional teams to troubleshoot and optimize processes during startup.

CQV & Equipment Readiness:

• Execute final verifications and modifications for new equipment.
• Partner with Quality, Automation, and Maintenance teams to ensure systems are production-ready.
• Assist in documentation and real-time problem-solving during initial runs.

Startup & On-Floor Support:

• Provide hands-on support during startup phase.
• Contribute to continuous improvement initiatives and operational efficiency.
• Interface with a 15-person team and coordinate with 10 existing members and automation support.