Process Engineer, II
CSL•Holly Springs, NC
About The Position
The Process Engineer II provides full-spectrum process engineering ownership for cGMP utility systems. Responsibilities include in-field troubleshooting, change management ownership, investigation support, and capital project delivery to ensure compliant, reliable, and fit-for-purpose utility operations.
Requirements
- Bachelor’s degree in Chemical, Mechanical, or related engineering discipline
- 3–7 years of process engineering experience in a cGMP-regulated environment
- Experience supporting pharmaceutical or biotechnology utility systems
- Strong understanding of cGMP and lifecycle engineering principles
- Experience with water systems, clean utilities, HVAC, or process gases
- Knowledge of FDA, EMA, ISPE, ASME, and USP standards
- Strong sense of ownership and accountability
- Excellent problem-solving and analytical skills
- Effective written and verbal communication
- Ability to work independently in a fast-paced environment
Nice To Haves
- Advanced degree or certification preferred
Responsibilities
- Serve as technical owner for assigned cGMP utility systems
- Ensure systems remain compliant, validated, and inspection-ready
- Maintain system documentation, specifications, and lifecycle assessments
- Lead hands-on troubleshooting of system upsets and performance issues
- Partner with Operations, Maintenance, Automation, and Quality teams
- Apply root cause analysis tools to eliminate recurring failures
- Act as change owner for utility-related changes
- Author and support investigations, CAPAs, and risk assessments
- Ensure alignment with validation and regulatory expectations
- Provide process engineering SME support to capital projects
- Develop and review URSs, specifications, and design packages
- Support FAT, SAT, commissioning, qualification, and handover activities
- Support audits, inspections, and regulatory responses
- Collaborate cross-functionally and with external vendors
- Provide technical guidance and mentorship as appropriate
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
