This listing was posted on Tip Top Job.
Senior Validation Engineer
Location:
Boulder, CO
Description:
About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing:related activities for GalXC(TM) and GalXC:Plus(TM) investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News and World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference? The Position Plan, manage and perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support engineers in writing user requirements, SOPs, IQ, OQ, PQ, design documents, final reports, cleaning studies, facility validation, computer validation, temperature mapping, audit support, CAPA, validation deviations, commission activities, change requests, deviation investigation and writing. Support validation activities associated with changes to existing and new systems. Process equipment includes synthesizer, deprotection systems, UF/DF, chromatography skids, glasswashers, buffer preparations systems, annealing tanks, vacuum concentration, cold rooms, stability changers, freezers, refrigerators, process utilities, process water, and lyophilization. Collaboration and coordination with Tech Ops, Facilities, contractors, IT, metrology and other key stakeholders to ensure the right quality, cost and timely completion of all validation deliverables. Relationships Associate Director. Essential Functions stylemargin:bottom:11.0px::Perform, review and approve validation/revalidation. Must be able to work and communicate effectively across multiple departments to schedule and perform validation/revalidation assignments:Review and approve documents in accordance with local, corporate and regulatory regulations:Collaborate, review and approve IQ, OQ and PQ protocols for systems/processes per approved timeframes:Support closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures and implement corrective actions which address and eliminate potential reoccurrence of the failures:Ensure executed protocol data reviewed is accurate and meets documented acceptance criteria:Responsible for Change Requests (CR's) related to revalidation and other validation activities:Review and approve validation procedures, specifications and quality documents for accuracy and compliance:Presentation and support for validation concepts and approaches with audits and inspections:Follow all safety and environmental requirements in the performance of duties:Operate in alignment with NNWay, demonstrating a Quality and cLEAN(R) Mindset at the Boulder site:Other accountabilities, as assigned Physical Requirements Moves equipment and /or supplies weighing up to 60 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50 of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder, scaffolding, or scissor lift. May be required to work at elevated heights. Occasionally works around odorous and /or hazardous materials. Qualifications stylemargin:bottom:11.0px::BA/BS in Engineering/pharmaceut
Posted:
May 1 on Tip Top Job
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