Senior Validation Engineer

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™ and GalXC-Plus™ 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 & 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 & 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 & writing. Support validation activities associated with changes to existing & 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 & coordination with Tech Ops, Facilities, contractors, IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all validation deliverables.

 

Relationships

Associate Director.

 

Essential Functions

• Perform, review & approve validation/revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform validation/revalidation assignments
• Review & approve documents in accordance with local, corporate & regulatory regulations
• Collaborate, review & approve IQ, OQ & 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 & implement corrective actions which address & eliminate potential reoccurrence of the failures
• Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
• Responsible for Change Requests (CR’s) related to revalidation & other validation activities
• Review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Presentation & support for validation concepts & approaches with audits & inspections
• Follow all safety & environmental requirements in the performance of duties
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset at the Boulder site
• Other accountabilities, as assigned

 

Physical Requirements

Moves equipment &/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 &/or hazardous materials.

 

Qualifications

• BA/BS in Engineering/pharmaceutical sciences, or equivalent years of relevant experience in Validation & GMP documentation required
• Minimum of five (5) years of validation related discipline experience in pharmaceutical or medical device industry required
• Experience in quality concepts including technical & compliance review of validation & quality documents preferred
• Experience in one or more core validation areas (equipment, clean & black utilities) preferred
• Experience in cGMP documentation practices & regulations preferred
• Advanced computer skills including experience in the use of Microsoft word, Excel, and Part 11 compliant temperature mapping software preferred
• Knowledge of statistical methods to support qualification activities for temperature mapping and cleaning