Katalyst CRO · 8 hours ago
Senior Process Engineer
Holly Springs, NC
Contract
Onsite
Senior LevelKatalyst Healthcares & Life Sciences is seeking a Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at their Holly Springs site. The role involves leading the design, review, and optimization of Clean-In-Place systems and associated utilities to ensure compliant and efficient manufacturing operations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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