CIP Senior Process Engineer / Senior Process Engineer

< data-start="234" data-end="261">Position Summary

We are seeking an experienced Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs, NC site. This fully onsite role requires strong hands-on expertise in Clean-In-Place (CIP) systems, process design, and supporting utilities. The successful candidate will be responsible for designing, reviewing, and optimizing CIP systems and associated utilities to ensure compliant, efficient, and reliable manufacturing operations in a GMP environment.

< data-start="810" data-end="839">Key Responsibilities

• Lead and support the design, review, and optimization of CIP systems for biopharmaceutical manufacturing processes

• Perform process design activities, including development and review of Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), and system layouts

• Review and evaluate system design documentation to ensure alignment with operational, safety, and regulatory requirements

• Provide technical expertise for utilities supporting CIP systems, including water systems, steam, chemical distribution, and waste handling

• Support implementation of process and utility design changes in a GMP-regulated environment

• Collaborate cross-functionally with Manufacturing, Engineering, Validation, Quality, and Facilities teams

• Ensure all designs comply with GMP, safety, and regulatory standards

• Support troubleshooting activities, continuous improvement initiatives, and process optimization efforts

< data-start="1785" data-end="1817">Required Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline

• Proven experience as a Process Engineer in a regulated pharmaceutical or biotechnology manufacturing environment

• Strong hands-on experience with Clean-In-Place (CIP) systems

• Demonstrated experience with:

  • Process and system design reviews

  • Process design documentation (PFDs, P&IDs)

  • Utility design and integration supporting CIP systems

• Solid understanding of GMP principles and regulated manufacturing environments

• Ability and willingness to work 100% onsite in Holly Springs, NC

< data-start="2451" data-end="2484">Preferred Qualifications

• Experience supporting large-scale biopharmaceutical manufacturing operations

• Familiarity with commissioning, qualification, and validation activities related to CIP systems

• Experience supporting new system installations or system upgrades

• Strong communication skills and ability to work effectively in cross-functional teams