Process Engineer, II
Position SummaryThe 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 ResponsibilitiescGMP Utility OwnershipServe as technical owner for assigned cGMP utility systemsEnsure systems remain compliant, validated, and inspection-readyMaintain system documentation, specifications, and lifecycle assessmentsIn-Field Troubleshooting & Operations SupportLead hands-on troubleshooting of system upsets and performance issuesPartner with Operations, Maintenance, Automation, and Quality teamsApply root cause analysis tools to eliminate recurring failuresChange Management & InvestigationsAct as change owner for utility-related changesAuthor and support investigations, CAPAs, and risk assessmentsEnsure alignment with validation and regulatory expectationsCapital Projects & Continuous ImprovementProvide process engineering SME support to capital projectsDevelop and review URSs, specifications, and design packagesSupport FAT, SAT, commissioning, qualification, and handover activitiesCompliance & Stakeholder EngagementSupport audits, inspections, and regulatory responsesCollaborate cross-functionally and with external vendorsProvide technical guidance and mentorship as appropriateRequired QualificationsEducationBachelor’s degree in Chemical, Mechanical, or related engineering disciplineAdvanced degree or certification preferredExperience3–7 years of process engineering experience in a cGMP-regulated environmentExperience supporting pharmaceutical or biotechnology utility systemsTechnical SkillsStrong understanding of cGMP and lifecycle engineering principlesExperience with water systems, clean utilities, HVAC, or process gasesKnowledge of FDA, EMA, ISPE, ASME, and USP standardsCore CompetenciesStrong sense of ownership and accountabilityExcellent problem-solving and analytical skillsEffective written and verbal communicationAbility to work independently in a fast-paced environmentAbout CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.Our BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belongingEqual Opportunity EmployerCSL 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 https://www.csl.com/accessibility-statement.Watch our ‘On the Front Line’ video to learn more about CSL Seqirus