Integration Validation Lead

Job Title: Integration Validation Lead

Location: Remote/WFH 

Duration: 9 months+ contract

CSV / Validation Lead, with MES experience considered a strong plus.

The ideal candidate will have 5–10 years of relevant experience. Computer Systems Validation (CSV) Lead

Key Responsibilities:

• The selected candidate will support client engagement teams in delivering projects within the Life Sciences domain, including:
• Leading computer systems validation activities to ensure GxP regulated systems are fit for intended use and compliant with regulatory expectations
• Defining and applying risk based validation and testing strategies across the system lifecycle
• Ensuring validation activities are effectively integrated with SDLC and delivery models while maintaining compliance
• Establishing and owning the overall validation strategy, including scope, approach, and alignment with quality and delivery models
• Leading validation workstreams to ensure timely execution, quality outcomes, and stakeholder alignment
• Overseeing validation documentation, traceability, and change management for validated systems
• Supporting data integrity, audit readiness, and ongoing compliance across regulated systems You will also be expected to work collaboratively within teams to consistently deliver high quality client services by demonstrating strong technical capabilities, professional knowledge, and the ability to build long term client relationships.

Skills and Attributes for Success

• Strong foundation in CSV, SDLC, and Agile delivery models
• Hands on experience with risk based validation and testing methodologies
• Solid understanding of GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity guidance
• Ability to translate regulatory expectations into practical, scalable validation approaches
• Experience working across manufacturing, quality, IT, and automation teams
• Clear, structured communication and strong documentation skills
• Ability to work effectively with diverse, cross functional teams
• Commitment to fostering an innovative, inclusive, and team oriented environment
• Demonstrated depth of technical expertise and professional knowledge

Required Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing, or a related field
• Minimum of three years of related professional experience (MBA strongly preferred but not required)
• 5–10 years of Life Sciences experience, including exposure to regulatory statutes, GxP business processes, system validations, risk management, compliance programs, or integration of risk management functions

Preferred Experience

• Experience validating and implementing MES and other ERP systems
• Hands on experience with Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems

Best Regards,

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David Roy | #LI-DR1  Accounts Manager – US Staffing | Charter Global Inc. |