Deliver compliance consulting services in FDA regulated markets.
Manage compliance consulting projects focused on Computerized System Validation (CSV).
Provide Data Integrity assessment and remediation.
Communicate across diverse customer organizations.
Stay current with applicable regulatory trends and regulations.

Requirements

B.S./B.A. in Engineering, Science, Information Technology, or related field.
4+ years of experience in Computer System Validation.
4+ years' experience in related Pharmaceutical or Healthcare Industries.
Experience in the validation of at least two computer system categories: clinical data/study management, automation control, laboratory systems, quality management systems, ERP, medical device software.
Must be able to quickly learn new software applications used in GxP activities.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Computer System ValidationData Integrity assessmentremediationvalidation of clinical data/study managementvalidation of automation controlvalidation of laboratory systemsvalidation of quality management systemsvalidation of ERPvalidation of medical device software

Soft Skills

communicationproject managementadaptability