Senior CSV Analyst - IT Compliance & Validation Lead

Biopharma Careers; Iowa (LA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Bonus

Paid time off

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental & family leave

Life & disability insurance

Tuition assistance

Employee referral awards

Job summary

Novo Nordisk is seeking a Subject Matter Expert in Computer Systems Validation to drive validation, process improvement, and IT compliance across our Clayton API site. You will ensure regulatory-aligned delivery, governance, and continuous improvement to support product quality, patient safety, and data integrity.

The role emphasizes collaboration with cross‑functional teams, hands-on validation activities, and leadership in CSV programs with an emphasis on FDA/EU standards and continuous

Qualifications

• Bachelor’s degree in IT, Engineering, Science, or relevant field.
• Master’s degree preferred.
• Minimum seven years IT compliance experience.
• Five years validation and testing of IT solutions.
• CSQE certification is preferred.
• COBIT certification is preferred.
• Lean Six Sigma Green Belt or Black Belt preferred.
• Experience with GxP, change management and deviation handling.
• Excellent writing and communication in English.

Responsibilities

• Validate IT infrastructure, systems, and computerized equipment supporting Laboratories, Manufacturing, and Facilities.
• Ensure IT solutions comply with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
• Develop validation deliverables including URS, DQ, IQ, OQ, PQ and related docs.
• Conduct risk assessments and mitigation strategies.
• Provide guidance on validation and qualification requirements to project teams.
• Lead audits and inspections as CSV SME and document outcomes.

Skills

IT compliance

Validation expertise

GxP knowledge

Documentation skills

Communication skills

Problem-solving

Education

Bachelor’s Degree in IT/Engineering/Science

Master’s degree preferred

Tools

HP ALM

COBIT

Lean Six Sigma

Job description

Novo Nordisk is seeking a Subject Matter Expert in Computer Systems Validation to drive validation, process improvement, and IT compliance across our Clayton API site. You will ensure regulatory-aligned delivery, governance, and continuous improvement to support product quality, patient safety, and data integrity.

The role emphasizes collaboration with cross‑functional teams, hands-on validation activities, and leadership in CSV programs with an emphasis on FDA/EU standards and continuous