Validation Lead MES (Pomsnet, Csv, Gxp)

Job Description

Job Summary :

We are looking for a seasoned Validation Lead with deep expertise in MES (POMSNet), Computer System Validation (CSV), and GxP-regulated environments within the Life Sciences domain. The candidate will lead end-to-end validation and testing for MES and integrated manufacturing systems, ensuring regulatory compliance, audit readiness, and high-quality project delivery. This role requires strong hands-on experience in POMS MES validation, CSA implementation, and stakeholder coordination across global teams.

Key Responsibilities

• Lead end-to-end CSV activities for MES and integrated systems in GxP environments
• Develop and execute validation strategies aligned with FDA, GAMP5, and CSA guidelines
• Create and review validation deliverables including Validation Plan, Risk Assessment, IQ/OQ/PQ, RTM, and VSR
• Drive validation and testing for POMS MES and related integrations
• Support MES implementation, upgrades, and enhancements in manufacturing environments
• Ensure compliance with regulatory standards and internal quality procedures
• Coordinate with QA, Manufacturing, IT, Vendors, and cross-functional stakeholders
• Manage defect tracking, test execution, and release validation activities
• Lead onsite and offshore validation/testing teams and ensure timely delivery
• Establish best practices, SOPs, checklists, and governance for GxP project execution
• Support CSA (Computer Software Assurance) adoption and audit readiness

Required Qualifications :

• 15+ years of overall IT experience
• 5+ years as Validation Lead in Life Sciences/Pharma
• 5+ years of Test Lead experience with hands-on testing deliverables
• 5+ years of strong CSV experience in regulated environments
• 2+ years of hands-on POMSNet MES validation and integration testing
• 4+ years of Life Sciences project experience (Manufacturing/Supply Chain preferred)
• 5+ years of direct customer and stakeholder management

Required Skills :

• Strong knowledge of GxP, CSV, CSA, and validation frameworks
• Hands-on experience with POMSNet MES validation
• Understanding of Life Sciences manufacturing business processes
• Expertise in validation documentation and audit compliance
• Excellent leadership, communication, and coordination skills
• Proven ability to manage global teams and deliver complex projects

Tools & Technologies :

• POMSNet MES
• JIRA, Confluence
• Micro Focus ALM (HP ALM)
• MS Office

Application Process:

Interested candidates can apply by sending their updated resume to xxxxxxxxxxxxxxx with the subject line “Validation Lead – MES (POMSNet) – Boston”.