Senior IT CSV Analyst - Validation & Compliance

BioSpace; Clayton (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid time off

Parental leave

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

You will collaborate with Engineering and Quality, develop validation deliverables, support audits, mentor staff, and drive process improvements while maintaining data integrity and patient safety.

Qualifications

• Bachelor’s degree in IT, Engineering, Science or related field.
• 7+ years IT compliance experience in pharma API/manufacturing preferred.
• 5+ years validation and testing IT solutions experience.
• CSQE, COBIT, Lean Six Sigma Green/Black Belt preferred.
• Excellent English writing and communication skills required.
• Experience with electronic application lifecycle software and audits preferred.

Responsibilities

• Participate in IT solutions validation for Infrastructure, Systems and Computerized Equipment.
• Ensure IT solutions comply with 21 CFR Part 11, EU Annex 11 and GAMP.
• Develop and review validation deliverables (URS, DQ, IQ/OQ/PQ, FAT/SAT).
• Conduct risk assessments and mitigation planning for compliance issues.
• Provide guidance to project teams on validation and qualification requirements.
• Monitor documentation and processes for regulatory compliance and continuous improvement.
• Collaborate with Engineering to prepare validation, requalification, and maintenance programs.
• Support audits/inspections with required CSV documentation.
• Lead CSV SME activities in audits and release to operations.
• Coach and mentor staff on CSV and process improvement.

Skills

IT compliance

Validation & Testing

GxP knowledge

English communication

Education

Bachelor’s Degree in IT/Engineering/Science

Master’s degree preferred

Tools

HP ALM

COBIT

Lean Six Sigma

Job description

You will collaborate with Engineering and Quality, develop validation deliverables, support audits, mentor staff, and drive process improvements while maintaining data integrity and patient safety.