What are the responsibilities and job description for the Validation Area Specialist - Finished Production position at BioSpace?
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.
What We Offer You
The Position
Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
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 timeframes. 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
Physical Requirements
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.
Qualifications
Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
Master's Degree preferred 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 documentation based on equipment manuals preferred
Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferred
Knowledge of standard operating procedures with attention to high-level concepts preferred
Ability to manage multiple tasks/deadlines & prioritize properly based on process needs preferred
Demonstrated strong skills in change management within NN preferred
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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.
What We Offer You
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
The Position
Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
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 timeframes. 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
Physical Requirements
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.
Qualifications
Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
Master's Degree preferred 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 documentation based on equipment manuals preferred
Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferred
Knowledge of standard operating procedures with attention to high-level concepts preferred
Ability to manage multiple tasks/deadlines & prioritize properly based on process needs preferred
Demonstrated strong skills in change management within NN preferred
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.