Senior Process Engineer jobs in United States
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Ecocareers · 1 day ago

Senior Process Engineer

Confidential company is seeking a Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at their Holly Springs site. This role requires strong hands-on technical expertise with Clean-In-Place (CIP) systems and involves the design, review, and optimization of these systems to ensure efficient manufacturing operations.

Staffing & Recruiting

Responsibilities

Lead and support CIP system design, review, and optimization for manufacturing processes
Perform process design activities, including development and review of process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and system layouts
Review and assess system design documentation to ensure alignment with operational, safety, and regulatory requirements
Provide technical expertise in utilities supporting CIP systems, including water systems, steam, chemical distribution, and waste handling
Support implementation of process and utility design changes in a GMP environment
Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, Quality, and Facilities
Ensure designs meet GMP, safety, and regulatory compliance standards
Participate in troubleshooting, continuous improvement initiatives, and process optimization efforts

Qualification

Clean-In-Place (CIP) systemsProcess designUtility designGMP principlesSystem design reviewsCommunication skillsCross-functional collaboration

Required

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 environment
Strong hands-on experience with Clean-In-Place (CIP) systems
Demonstrated experience in system design reviews
Demonstrated experience in process design and documentation
Demonstrated experience in utility design and utility-system integration related to CIP
Solid understanding of GMP principles and regulated manufacturing environments
Ability to work 100% onsite in Holly Springs, NC
Experience supporting large-scale biopharmaceutical manufacturing operations
Familiarity with commissioning, qualification, and validation activities related to CIP systems
Strong communication skills and ability to work cross-functionally

Company

Ecocareers

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Funding

Current Stage
Early Stage
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