Validation Area Specialist - Finished Production

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now.

FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.

Reports to Senior Project Manager, Site Capacity & Upfit.

• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols.
• Ownership of Change Requests (CR’s) related to project validation responsibilities.
• Perform compliance & technical reviews/approvals of protocols & protocol data.
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation.
• Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved time frames. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment.
• Serves as a source of expertise in the group for validating new systems.
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations.
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
• Create & modify existing validation procedures & configuration item lists (CIL’s) as required.
• Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
• Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
• Identify process improvements before equipment, systems or processes are placed under change control during validation.
• Budget oversight as needed.
• Contractor scheduling & oversight as needed.
• Leads validation activities assigned by overall project manager.
• Other accountabilities, as assigned.

May 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 color vision based on role. May require the ability to work in loud noise environments with hearing protections.

• Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required.
• Master's Degree preferred.
• Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment required.
• Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents required.
• Demonstrated experience using root-cause analysis techniques to solve problems preferred.
• Ability to read, write & understand complicated product documentation preferred.
• Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements preferred.
• Ability to write technical…