Position: Integration Validation Specialist / Lead
Location: Manhattan, New York 10001 (First Week Onsite)
Duration: 9 Months
Job Summary The Integration Validation Specialist / Lead will lead and support middleware-centric integration validation, MES, and other related manufacturing solutions across pharmaceutical manufacturing sites. The role focuses on validating shop-floor to enterprise integrations to ensure compliant, reliable, and scalable manufacturing operations in a GxP environment. This position supports Rockwell PharmaSuite MES and related manufacturing platforms, enabling continuous enhancements and site deployments while maintaining systems in a validated state. The role emphasizes integration validation strategy, Agile validation, team leadership, risk-based testing, and data integrity.
Key Responsibilities
Lead middleware integration validation, ensuring compliant data exchange between shop-floor systems, MES and other related solutions, and enterprise platforms.
Define and drive overall validation strategies for middleware, MES, and integrated manufacturing solutions.
Lead end-to-end integration validation and testing, including interfaces, data flows, error handling, and recovery scenarios.
Validate MES and related manufacturing solutions supporting configuration changes, enhancements, and multi-site deployments.
Lead validation team meetings, Agile ceremonies, and cross-functional working sessions with IT, Automation, Quality, and Business stakeholders.
Execute validation activities within an Agile delivery model, enabling incremental releases while maintaining compliance.
Apply risk-based validation approaches aligned with GxP, FDA 21 CFR Part 11, and GAMP 5.
Ensure adherence to ALCOA+ data integrity principles across integrated manufacturing systems.
Author, review, and approve validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, and summary reports.
Provide quality oversight to maintain systems in a validated state and ensure audit readiness.
Support governance activities including change control, deviations, and periodic reviews.
Required Qualifications
Bachelor s/Master s degree in Engineering, Computer Science, Life Sciences, or a related field.
10+ years of experience in GxP system validation with strong focus on middleware, MES, and manufacturing system integrations.
Hands-on experience with MES platforms (Rockwell PharmaSuite preferred) and middleware-based integrations.
Proven experience leading integration validation efforts across shop-floor, automation, and enterprise systems.
Experience supporting Agile validation in regulated environments.
Strong knowledge of data integrity (ALCOA+), FDA 21 CFR Part 11, and risk-based testing.
Key Skills
Middleware integration validation, MES and related manufacturing solutions, shop-floor to enterprise integrations, validation strategy and leadership, Agile validation, risk-based testing, data integrity (ALCOA+), GxP compliance, and cross-functional collaboration.