Senior CSV Engineer / Senior Validation Engineer

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $70.5k - $118.1k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.

📋 Description

• Lead SAP validation strategy and CSA/CSV activities for SAP S/4HANA, ECC, and integrated GxP systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Annex 11 requirements • Provide oversight and approval of validation lifecycle deliverables, including URS, risk assessments, validation plans, test protocols, traceability matrices, and validation summary reports • Support SAP integrations with enterprise applications such as MES, LIMS, Veeva, TrackWise, and other regulated systems, ensuring data integrity and end-to-end process compliance • Review change controls, impact assessments, system enhancements, and upgrades to maintain validated state and inspection readiness • Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring alignment with SDLC and quality procedures • Monitor validation KPIs, drive continuous improvement initiatives, and provide SME support during audits, inspections, and cross-functional project activities

🎯 Requirements

• 5+ 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-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