Senior Validation & Automation Specialist

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 110,000 - 155,000; Full time

Benefits offered by this job

Competitive pay

Annual bonus

14 paid holidays

Health, dental, vision insurance

401K with company match

Parental leave

Tuition assistance

Life & disability insurance

Product access

Referral program

Job summary

Novo Nordisk seeks an experienced Validation Lead to provide and oversee validation for IT and automation projects at our North Carolina facility. You will manage IV, OV, PV validation activities, drive change control, and ensure compliance with 21 CFR Part 11 and GAMP5.

Join a global team focused on quality and patient safety, emphasizing leadership, project management, and continuous improvement across cross-functional groups.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical field; proven experience.
• Master's Degree preferred.
• Seven+ years validation or quality discipline experience in pharmaceutical environment.
• Experience with regulatory requirements & industry standards (21 CFR Part 11, GAMP5, ISO, FDA/ICH).
• Demonstrated root-cause analysis and leadership in projects.

Responsibilities

• Provide validation & technical support through preparation, execution, data analysis, and report writing for IV, OV & PV protocols.
• Ownership of Change Requests related to validation responsibilities.
• Perform compliance & technical reviews/approvals of protocols & protocol data.
• Author PQMPs, VPLs, and other key validation documentation.
• Author & execute assigned IV, OV & PV protocols for direct impact systems.
• Lead validation activities with minimal guidance and serve as a group expert.
• Identify process improvements before change control during validation.
• Budget oversight and contractor scheduling as needed.
• Leads validation activities assigned by the overall project manager.

Skills

Leadership

Project management

Root cause analysis

Regulatory compliance

Communication

Technical writing

Education

Bachelor's degree in Engineering/CS or related technical field

Master's degree preferred

Job description

Novo Nordisk seeks an experienced Validation Lead to provide and oversee validation for IT and automation projects at our North Carolina facility. You will manage IV, OV, PV validation activities, drive change control, and ensure compliance with 21 CFR Part 11 and GAMP5.

Join a global team focused on quality and patient safety, emphasizing leadership, project management, and continuous improvement across cross-functional groups.