Sr. Plant Engineer 1 (Utilities), Gene Therapy at Biogen in Research Triangle Park, North Carolina

Job Description:

Job DescriptionAbout This RoleBiogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Sr. Plant Engineer I (Utilities), Gene Therapy supports capital and operational projects including design, commissioning protocol development, overseeing FAT and SAT testing, and qualification of GxP systems. Equipment of ownership will include clean utilities (WFI / Clean Steam), Clean Gasses (CO2, CA, O2, N2), Process Glycol, Waste Systems and associated control systems required for new manufacturing and support areas. This role leads multi-function teams to implement change and improve on existing engineering design, construction, commissioning & qualification processes. Assignments are complex in nature where an ability to recognize deviation from accepted practice is required. Judgment is also required in resolving problems & making routine recommendations.What You'll DoIdentify and lead equipment related projects, capital projects, and modificationsMaintain personal training, goal development / completion, compliance workflow tracking, & progress trackingProvide project management oversight for small to large Opex projectsLead startup & execute commissioning for new and modified systemsOversee qualification & validation of process utilities and GxP systemsWork with facilities teams to establish PMs, calibrations and spare parts for owned equipmentTroubleshoots equipment systems and supports associated automation system troubleshooting efforts.Lead investigations for compliance workflows (CAPAs, deviations) and represent systems of ownership in compliance auditsWho You AreYou are dedicated to contributing to the generation of pioneering gene therapies. You can manage small to medium engineering projects with little direction, as well as work with and provide direction to contractors. QualificationsRequired SkillsExperience in the pharmaceutical / biotech industry supporting clean utilities (WFI / clean Steam) and clean gasses (CO2, CA, O2, N2)Plant utility experience including process glycol, plant steam, vacuum and waste systems (biowaste & pH neut)Experience with documentation requirements for GMP manufacturing facilities including Change Control and validation systemsExperience with equipment testing including factory acceptance testing (FAT), site acceptance testing (SAT), commissioning and qualification.Practical knowledge and application of GMP and FDA/EMA regulations, and audit supportExcellent verbal and written communication skills, demonstrated technical proficiency and creativity, and excellent organizational and time management skillsCompetency in PLC, MS Word, MS Excel, MS Power Point and MS ProjectMust be able to prioritize multiple commitments and technical problemsMust have the ability to shift priorities according to changes in department / facility needs and be open to different ideas / approachesMust be willing to work in an open office environmentPreferred SkillsWorking with ozone technology for high purity water storage and distributionWriting protocols, user requirements, and system design documents experience preferableExperienced with operation and troubleshooting of PLC (Programmable Logic Controllers) automationEducationBachelor's Degree with a minimum of 4 years' experience OR MBA/MS with a minimum of 2 years in pharmaceutical or biotech manufacturing environmentAdditional InformationMust be willing to participate in an on-call rotation, can work rotating shifts, extended shifts and weekends as needed.Why Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.PDN-976aad5d-2b59-4793-95fa-2a3b52320369