ThePositionValidation Lead (Project Quality) for IFP expansion projects. Provides comprehensive validation subject matter expertise (i.e., equipment, facility, cleaning, sterilization, product, process validation). Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual & directs project areas in developing compliant validation strategies.
RelationshipsReports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions- Build Subject Matter Expert (SME) understanding of the Novo Nordisk science & risk-based validation procedures
- Provide SME level knowledge to project groups
- Leads the development of all electronic validation structure
- Identify & implement lean project execution activities
- Translate procedural requirements within the validation area into practical workflows guiding the project execution
- Identify & implement improvements that support lean project execution
- Build strong cross-functional relations with Novo Nordisk project organization & validation project contributors (local & abroad)
- Other accountabilities, as assigned.
Physical RequirementsMay move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications- Bachelor's Degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience required
- MA/MS degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience preferred
- Minimum of eight (8) years of equipment & facilities validation experience preferred
- SME experience from pharma production environment preferred
- Preferred knowledge of Novo Nordisk science & risk-based validation procedures preferred
- Proven experience with quality systems preferably within pharma industry preferred
- Experienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical device manufacturing, laboratory, or business environment preferred
- Project execution experience, preferably in a Novo Nordisk context, as supplier or internal SME preferred
- Understanding of lean project execution principles, continuous improvements & application in a small & large-scale project environment preferred
- Solid project execution experience & the ability to link/translate validation procedures & principles to practical hands-on project work processes preferred
- Experience in working with external engineering consultants & ensuring integration of NN quality requirements preferred
- Familiar with LEAN & continuous improvement methodologies preferred
- Written & verbal communication skills to allow interaction with all levels of operations & management preferred
- Proven expertise in project management, in planning/organization, &/or project execution preferred
- Follow-up & completion preferred
- SME level skills within validation & the links to project execution planning preferred
