Process Engineer, II

Position Summary 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. Key Responsibilities cGMP Utility Ownership Serve as technical owner for assigned cGMP utility systems Ensure systems remain compliant, validated, and inspection-ready Maintain system documentation, specifications, and lifecycle assessments In-Field Troubleshooting & Operations Support 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 Change Management & Investigations Act as change owner for utility‑related changes Author and support investigations, CAPAs, and risk assessments Ensure alignment with validation and regulatory expectations Capital Projects & Continuous Improvement Provide process engineering SME support to capital projects Develop and review URSs, specifications, and design packages Support FAT, SAT, commissioning, qualification, and handover activities Compliance & Stakeholder Engagement Support audits, inspections, and regulatory responses Collaborate cross‑functionally and with external vendorsProvide technical guidance and mentorship as appropriate Required Qualifications Education Bachelor’s degree in Chemical, Mechanical, or related engineering discipline Advanced degree or certification preferred Experience 3–7 years of process engineering experience in a cGMP‑regulated environment Experience supporting pharmaceutical or biotechnology utility systems Technical Skills 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 Core Competencies 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 Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr