Validation Area Specialist I
Novo Nordisk
5 hours ago
On-site
Clayton, NC
Operations
What We Offer You:
- Leading pay and annual performance bonus for all positions
- 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:
- Plan, manage, and 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 and new systems as assigned
- Collaborate and coordinate with IT, Metrology, and other key stakeholders to ensure quality, cost effectiveness, and timely deliverables
Essential Functions:
- Perform, review, and approve validation/revalidation; communicate and coordinate across departments to schedule/perform assignments
- Review and approve documents per local, corporate, and regulatory requirements
- Collaborate on reviewing/approving protocols for systems/processes within approved timeframes
- Identify root causes of failures; implement corrective actions to prevent recurrence; support investigation closure using root-cause analysis techniques
- Ensure executed protocol data is accurate and meets documented acceptance criteria
- Manage Change Requests (CRs) related to revalidation and other validation activities as assigned
- Review and approve validation procedures, specifications, and quality documents for accuracy and compliance
- Provide support for validation concepts/approaches with audits and inspections as assigned
- Support change control and identify improvement opportunities
- Author and review validation procedures, specifications, and quality documents
- Operate in alignment with NNWay and demonstrate a Quality & cLEAN Mindset
- Follow all safety and environmental requirements; other duties as assigned
Qualifications:
- Required: Bachelor’s degree in engineering, pharmaceutical sciences, or related field (accredited) and minimum 2 years validation-related experience in pharmaceutical or medical device industry
- In lieu of BS: Associate’s degree (accredited) and minimum 4 years relevant validation experience
- In lieu of BS with 2 years experience: High School Diploma/equivalent and minimum 6 years relevant validation experience
- Preferred: Experience with quality concepts (technical and compliance review of validation/quality documents)
- Preferred: Experience in core validation areas (equipment, sterilization, cleaning, process clean & black utilities, or computer validation)
- Preferred: Experience in cGMP documentation practices and regulations
- Preferred: Basic computer skills (Microsoft Word, Excel, etc.)
- Preferred: Knowledge of statistical methods
- Preferred: Strong oral and written communication skills
- Preferred: Experience with validation test equipment (e.g., temperature mapping equipment such as Ellab Validator)
- Preferred: Experience working with cross-functional teams
- Preferred: Root-cause analysis problem-solving knowledge
- Plus: Demonstrated expertise in planning/organizing, managing execution, checking results, and revising work plans for complex cross-functional problem resolution
Physical Requirements:
- Ability to work in an open office environment; possibility of frequent distraction
- Ability to travel up to 10% of the time (may vary by role)
Application Instructions:
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only; not for application status inquiries).
- Leading pay and annual performance bonus for all positions
- 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:
- Plan, manage, and 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 and new systems as assigned
- Collaborate and coordinate with IT, Metrology, and other key stakeholders to ensure quality, cost effectiveness, and timely deliverables
Essential Functions:
- Perform, review, and approve validation/revalidation; communicate and coordinate across departments to schedule/perform assignments
- Review and approve documents per local, corporate, and regulatory requirements
- Collaborate on reviewing/approving protocols for systems/processes within approved timeframes
- Identify root causes of failures; implement corrective actions to prevent recurrence; support investigation closure using root-cause analysis techniques
- Ensure executed protocol data is accurate and meets documented acceptance criteria
- Manage Change Requests (CRs) related to revalidation and other validation activities as assigned
- Review and approve validation procedures, specifications, and quality documents for accuracy and compliance
- Provide support for validation concepts/approaches with audits and inspections as assigned
- Support change control and identify improvement opportunities
- Author and review validation procedures, specifications, and quality documents
- Operate in alignment with NNWay and demonstrate a Quality & cLEAN Mindset
- Follow all safety and environmental requirements; other duties as assigned
Qualifications:
- Required: Bachelor’s degree in engineering, pharmaceutical sciences, or related field (accredited) and minimum 2 years validation-related experience in pharmaceutical or medical device industry
- In lieu of BS: Associate’s degree (accredited) and minimum 4 years relevant validation experience
- In lieu of BS with 2 years experience: High School Diploma/equivalent and minimum 6 years relevant validation experience
- Preferred: Experience with quality concepts (technical and compliance review of validation/quality documents)
- Preferred: Experience in core validation areas (equipment, sterilization, cleaning, process clean & black utilities, or computer validation)
- Preferred: Experience in cGMP documentation practices and regulations
- Preferred: Basic computer skills (Microsoft Word, Excel, etc.)
- Preferred: Knowledge of statistical methods
- Preferred: Strong oral and written communication skills
- Preferred: Experience with validation test equipment (e.g., temperature mapping equipment such as Ellab Validator)
- Preferred: Experience working with cross-functional teams
- Preferred: Root-cause analysis problem-solving knowledge
- Plus: Demonstrated expertise in planning/organizing, managing execution, checking results, and revising work plans for complex cross-functional problem resolution
Physical Requirements:
- Ability to work in an open office environment; possibility of frequent distraction
- Ability to travel up to 10% of the time (may vary by role)
Application Instructions:
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only; not for application status inquiries).