- 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 validation preferred
- Strong oral & written communication skills preferred
- Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), or equivalent required preferred
- Experience in project team collaboration & support. Experience with working with Quality Control & tracking testing requirements preferred
- Beginning knowledge of problem-solving using root-cause analysis techniques to solve problems preferred
- Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus The base compensation range for this position is $80,000 to $120,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on 05/22/2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications. -
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Senior Validation Engineer - Colorado, United States - Novo Nordisk
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 GalXCTM and GalXC-PlusTM 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
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