Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Validation 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.
*Verista is an equal opportunity employer.
National (US) Range
$87,780 — $136,225 USD
Benefits
Why 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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com