Lead Validation Engineer (Data Lake / CSV Engineer)

Description

A team of 500 experts partners with the world's most recognisable brands in the life science industry to solve their business needs. The nature of the business is to empower growth and innovation within the scientific community and to help researchers, organisations, and companies solve some of the world's most pressing healthcare challenges. The organisation provides innovative solutions and services that empower informed decision-making, resulting from significant investment in its people and capabilities.

Its ability to grow is driven by world-class people who thrive in a team environment and share the mission to enable life sciences clients to improve lives. Its talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

• The company empowers and supports its colleagues.
• It commits to client success at every turn.
• It has the courage to do the right thing.
• It encourages an inclusive environment where colleagues feel respected, engaged, and challenged.
• It constantly acquires new skills and learns from experience to enhance 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 and existing validation deliverables, and identify opportunities to simplify and modernise 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 minimise 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 a 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.

The company is an equal opportunity employer.

National (US) Range: $90,000 - $136,225 USD

Benefits - Why Choose This Opportunity?

• High growth potential and fast-paced organisation 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
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement