What are the responsibilities and job description for the Validation Area Specialist I position at BioSpace?
About The Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.
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
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Plan, manage & perform low to moderately complex validation projects and activities. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems as assigned. Process equipment supported includes propagation, fermenters, media sterilizers and the related supporting equipment. Collaborate & coordinate with IT, Metrology & other key stakeholders to ensure quality, cost effectiveness in alignment with budget targets & timely completion of all deliverables.
Relationships
Reports to Manager, Director.
Essential Functions
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 protocols for systems/processes per approved timeframes
Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures, to include supporting investigation closure per approved timeframes using root cause analysis techniques
Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
Responsible for Change Requests (CR’s) related to revalidation & other validation activities as assigned
Review & approve validation procedures, specifications & quality documents for accuracy & compliance
Provide support for validation concepts & approaches with audits & inspections as assigned
Support change control process and identify opportunities for improvements
Author & review validation procedures, specifications & quality documents for accuracy & compliance
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 Requirements
Ability 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 and a minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required
In lieu of BS degree two (2) years of experience, may consider an Associate’s Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university required with a minimum of four (4) years of relevant validation experience in pharmaceutical or medical device industry required
In lieu of BS degree with two (2) years of experience, may consider a High School Diploma or equivalent required with a minimum of six (6) years of relevant validation 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, sterilization, cleaning, process clean & black utilities or computer validation) preferred
Experience in cGMP documentation practices & regulations preferred
Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
Knowledge of statistical methods preferred
Strong oral & written communication skills preferred
Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
Experience working with cross functional teams 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
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.
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.
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
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Plan, manage & perform low to moderately complex validation projects and activities. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems as assigned. Process equipment supported includes propagation, fermenters, media sterilizers and the related supporting equipment. Collaborate & coordinate with IT, Metrology & other key stakeholders to ensure quality, cost effectiveness in alignment with budget targets & timely completion of all deliverables.
Relationships
Reports to Manager, Director.
Essential Functions
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 protocols for systems/processes per approved timeframes
Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures, to include supporting investigation closure per approved timeframes using root cause analysis techniques
Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
Responsible for Change Requests (CR’s) related to revalidation & other validation activities as assigned
Review & approve validation procedures, specifications & quality documents for accuracy & compliance
Provide support for validation concepts & approaches with audits & inspections as assigned
Support change control process and identify opportunities for improvements
Author & review validation procedures, specifications & quality documents for accuracy & compliance
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 Requirements
Ability 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 and a minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required
In lieu of BS degree two (2) years of experience, may consider an Associate’s Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university required with a minimum of four (4) years of relevant validation experience in pharmaceutical or medical device industry required
In lieu of BS degree with two (2) years of experience, may consider a High School Diploma or equivalent required with a minimum of six (6) years of relevant validation 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, sterilization, cleaning, process clean & black utilities or computer validation) preferred
Experience in cGMP documentation practices & regulations preferred
Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
Knowledge of statistical methods preferred
Strong oral & written communication skills preferred
Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
Experience working with cross functional teams 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
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.