The PositionServe as the Subject Matter Expert (SME) for planning, managing & performing high complexity validation activities and projects. Support engineers in writing change requests, deviation investigation & writing. Support validation activities associated with changes to existing & new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables. Serve as a mentor to junior team members.
RelationshipsReports to Manager, Director.
Essential Functions- Provide SME level knowledge and guidance to team members and stakeholders regarding validation activities, initiatives and projects
- Resolve validation related issues through actions leading to rapid, effective decision-making, to include sharing decision with team members and stakeholders in a timely and clear manner
- Perform, review & approve validation/revalidation & PSE activities
- Identifies and supports/performs remediation of validation compliance gaps for the department
- Review & approve documents in accordance with local, corporate & regulatory regulations
- Collaborate, review & approve protocols for systems/processes per approved timeframes
- Lead the 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
- Handle deviations related to revalidation & other validation activities
- 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
- Translate procedural requirements within the validation area into practical workflows guiding the project execution
- Identify & implement improvements that support risk-based validation execution for the site
- Build strong cross-functional relations with Novo Nordisk project organization & validation project contributors (local & abroad)
- Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).
Qualifications- Bachelor's Degree in Engineering, Pharmaceutical Sciences or related field of study from an accredited university required, with a minimum of seven (7) years of relevant validation experience in the pharmaceutical or medical device industry required
- In lieu of BS degree with a minimum of seven (7) years of experience, may consider an Associate's Degree in engineering, pharmaceutical sciences or related field of study from an accredited university required with a minimum of nine (9) years of relevant validation experience in pharmaceutical or medical device industry required
- In lieu of BS degree with a minimum of seven (7) years of experience, may consider a High School Diploma or equivalent required with a minimum of eleven (11) years of relevant validation experience in pharmaceutical or medical device industry required
- Experience in quality concepts including technical & compliance review of validation & quality documents required
- Experience in one or more core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) required
- Experience in cGMP documentation practices & regulations required
- Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments
- Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
- Knowledge of statistical methods preferred
- Strong oral & written communication skills required
- Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
- Demonstrated experience using root-cause analysis techniques to solve problems required
- Expert in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a required
