Job Description
Must Have Technical/Functional Skill 8-10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
Hands-on experience with validation deliverables:
VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports. Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles. Experience validating SDLC/CSV
across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications). Familiarity with GAMP 5 and risk-based validation approach. Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing. Working knowledge of change control, deviation management, CAPA, and periodic review. Good documentation practices; strong stakeholder management and communication skills. Roles & Responsibilities Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures. Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based). Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing. Develop and execute IQ/OQ/PQ
(or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing. Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations. Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate. Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities. Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions. Mentor junior CSV team members; contribute to process improvements, templates, and best practices. Salary Range:
$100,000-$120,000 a year TCS Employee Benefits Summary:
Discretionary Annual Incentive. Comprehensive Medical Coverage:
Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support:
Maternal & Parental Leaves. Insurance Options:
Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth:
Commuter Benefits & Certification & amp; Training Reimbursement. Time Off:
Vacation , Time Off, Sick Leave & Holidays. Legal & Financial Assistance:
Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1 Location Wilmington, DE Job Function TECHNOLOGY
Role Technical Lead Job Id 411993 Desired Skills Decision Making Salary Range $100,000-$120,000 a year Desired Candidate Profile Qualifications :
BACHELOR OF COMPUTER
SCIENCE
