What are the responsibilities and job description for the Validation Area Specialist III - Virginia position at BioSpace?
About The Department
For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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.
Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.
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
Serve 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.
Relationships
Reports 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 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, 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
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.
For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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.
Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.
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
Serve 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.
Relationships
Reports 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 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, 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
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.