DescriptionValidation Engineer (Data Lake) Responsibilities:Qualification Strategy & Validation Leadership- Lead qualification activities for an enterprise cloud-based Data Lake platform using modern, risk-based CSA methodologies.
- Assess the current architecture, existing validation deliverables, and identify opportunities to simplify and modernize qualification activities while maintaining compliance.
- Develop and implement a scalable qualification model supporting future onboarding of GxP systems, data sources, interfaces, and pipelines.
- Establish sustainable validation and governance procedures supporting both GxP and non-GxP use cases.
Validation Planning & Documentation- Author and maintain:
- Data Lake Validation Plan
- Requirements Specifications
- Technical Specifications and As-Built Configuration Documentation
- Infrastructure Qualification (IQ) Protocols
- Operational Qualification (OQ) Protocols
- Validation Summary Reports
- Test Summary Reports
- Develop sustainable documentation approaches that leverage platform automation and minimize unnecessary documentation.
Testing & Verification- Define streamlined testing strategies focused on critical infrastructure and business processes.
- Facilitate and coordinate testing activities executed by the Data and Infrastructure teams.
- Implement targeted verification approaches aligned with CSA principles.
- Ensure validation deliverables support ongoing lifecycle management and change control.
Governance & Lifecycle Management- Develop and implement governance procedures for the enterprise data platform.
- Establish change control processes supporting:
- GxP data source onboarding
- Data pipeline qualification
- Interface assessments
- Ongoing platform enhancements
- Develop Data Lake Administration SOPs and associated work instructions.
- Support implementation and governance of Power BI solutions used for GxP business processes.
Compliance & Risk Management- Ensure alignment with:
- GAMP 5 Second Edition
- Computer Software Assurance (CSA) guidance
- 21 CFR Part 11
- EU GMP Annex 11
- Data Integrity requirements
- Good Documentation Practices (GDP)
- Leverage supplier assessments, cloud platform controls, and risk-based verification methodologies.
Requirements:- Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or related discipline.
- 8+ years of Computer System Validation (CSV), CSA, or IT Compliance experience within pharmaceutical, biotechnology, or regulated environments.
- Strong experience qualifying cloud-based platforms and infrastructure.
- Demonstrated experience implementing risk-based CSA methodologies.
- Deep understanding of:
- GAMP 5 Second Edition
- FDA CSA Guidance
- 21 CFR Part 11
- EU Annex 11
- Data Integrity principles
- Change Management and SDLC processes
- Experience authoring and executing validation documentation.
- Strong stakeholder management and communication skills.
Preferred Qualifications:Experience with one or more of the following technologies:
- Microsoft Azure
- Azure Data Lake Storage
- Azure Data Factory
- Databricks
- Microsoft Fabric
- Power BI
Additional preferred experience:
- Enterprise Data Lakes
- Data Governance and Data Engineering
- Analytics Platforms
- GxP Data Pipelines and Interfaces
- Infrastructure Qualification
- SaaS, PaaS, and Cloud Validation
- Pharmaceutical Manufacturing, Quality, or R&D systems
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.National (US) Range
$87,780-$136,225 USD
BenefitsWhy Choose Verista?
- 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
For more information about our company, please visit us at Verista.com
