Senior CSV Engineer, Senior Validation Engineer
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Job Description
Senior Validation Engineer leading the development of validation strategies for life sciences clients. Overseeing compliance and governance of validation lifecycle deliverables in a remote role.
Responsibilities:
- Lead development of the validation strategy within the first 30 days of onboarding
- Oversee CSA/CSV compliance execution aligned with the customer SDLC and quality procedures
- Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary)
- Ensure readiness for formal testing and completeness of change control documentation
- Support CMDB governance and provide guidance on validation and testing tools
- Monitor KPI adherence including approval cycle time and traceability coverage
Requirements:
- 8–12+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
- Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance
- Strong experience with SAP or enterprise platform validation in GxP environments
- Proven ability to review/approve validation documentation and oversee testing governance
- Experience working remotely with global stakeholders
- Experience supporting S/4HANA upgrades or large enterprise transformation programs
- Familiarity with ALCOA+ documentation principles and quality governance frameworks
- Prior lead or architect-level CSA/CSV role
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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