Project Quality Assurance Validation Lead - Site Capacity
Novo Nordisk
6 hours ago
On-site
Clayton, NC
Operations
Validation Lead (Project Quality) for IFP expansion projects.
Essential Functions / Responsibilities:
- Provide comprehensive validation subject matter expertise (equipment, facility, cleaning, sterilization, product, process validation)
- Build SME understanding of Novo Nordisk science and risk-based validation procedures
- Provide SME level knowledge to project groups
- Lead development of electronic validation structure
- Identify and implement lean project execution activities
- Translate validation procedural requirements into practical workflows for project execution
- Identify and implement improvements supporting lean project execution
- Build strong cross-functional relationships with project and validation contributors (local and abroad)
Qualifications:
- Bachelor’s Degree in pharmaceutical, engineering, or other technical science field, or equivalent combination of education and experience (required)
- MA/MS degree in relevant field or equivalent combination (preferred)
- Minimum 8 years equipment and facilities validation experience (preferred)
- SME experience from pharma production environment (preferred)
- Knowledge of Novo Nordisk science and risk-based validation procedures (preferred)
- Proven experience with quality systems in pharma industry (preferred)
- Experience developing/implementing/validating/maintaining equipment and facilities (preferred)
- Project execution experience, preferably in a Novo Nordisk context (preferred)
- Lean/continuous improvement and ability to translate validation principles into hands-on execution (preferred)
Physical Requirements:
- May move equipment/supplies up to 33 pounds; may be on feet up to a 12-hour shift; corrected vision to 20/20 or 20/25; may require color vision; ability to work in loud noise environments with hearing protection.
Benefits (explicitly stated):
- Leading pay and annual performance bonus; paid time off (14 paid holidays)
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus possible match; paid parental and family medical leave
- Tuition assistance; life and disability insurance; employee referral awards
Application Instructions:
- For accommodation requests only, call 1-855-411-5290.
Essential Functions / Responsibilities:
- Provide comprehensive validation subject matter expertise (equipment, facility, cleaning, sterilization, product, process validation)
- Build SME understanding of Novo Nordisk science and risk-based validation procedures
- Provide SME level knowledge to project groups
- Lead development of electronic validation structure
- Identify and implement lean project execution activities
- Translate validation procedural requirements into practical workflows for project execution
- Identify and implement improvements supporting lean project execution
- Build strong cross-functional relationships with project and validation contributors (local and abroad)
Qualifications:
- Bachelor’s Degree in pharmaceutical, engineering, or other technical science field, or equivalent combination of education and experience (required)
- MA/MS degree in relevant field or equivalent combination (preferred)
- Minimum 8 years equipment and facilities validation experience (preferred)
- SME experience from pharma production environment (preferred)
- Knowledge of Novo Nordisk science and risk-based validation procedures (preferred)
- Proven experience with quality systems in pharma industry (preferred)
- Experience developing/implementing/validating/maintaining equipment and facilities (preferred)
- Project execution experience, preferably in a Novo Nordisk context (preferred)
- Lean/continuous improvement and ability to translate validation principles into hands-on execution (preferred)
Physical Requirements:
- May move equipment/supplies up to 33 pounds; may be on feet up to a 12-hour shift; corrected vision to 20/20 or 20/25; may require color vision; ability to work in loud noise environments with hearing protection.
Benefits (explicitly stated):
- Leading pay and annual performance bonus; paid time off (14 paid holidays)
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus possible match; paid parental and family medical leave
- Tuition assistance; life and disability insurance; employee referral awards
Application Instructions:
- For accommodation requests only, call 1-855-411-5290.