Role & seniority: SAP Validation Lead (Contract)

Stack/tools: SAP, Product Serialization systems, MES; ALM, DMS, JIRA; Agile and Waterfall methodologies; CSL QMS; familiarity with US-DSCSA

Top 3 responsibilities

Lead end-to-end validation activities for GxP applications (SAP, serialization, MES), including Validation Plan, Validation Summary Report, and RTM
Create and review requirement specs, functional specs/user stories, test scripts with traceability; perform risk assessments linked to test cases; ensure data readiness and evidence in test protocols
Manage change implementation for small changes (Impact Assessment, Test Plan/Results, Defects, RTM); act as CSA/Validation SME/Test Manager as needed; oversee defect management and deliverables quality

Must-have skills

12+ years in validating systems with GxP compliance and CSV experience
Strong knowledge of end-to-end validation, compliance analysis, and regulatory requirements
Experience with Agile and Waterfall software development; ability to author/review Validation Plans, Validation Summary Reports, RTMs; proficiency with ALM, DMS, JIRA

Nice-to-haves

Prior experience implementing US-DSCSA
CSA/Validation SME/Test Manager experience in CSL QMS
Stakeholder relationship building across regions
Location & work type: King of Prussia, PA; Contract role; on-site with potential regional stakeholder engagement

Full Description

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We are looking for SAP Validation Lead for our client in King of Prussia, PA

Job Title: SAP Validation Lead

Job Location: King of Prussia, PA

Job Type: Contract

Job Description

Pay Range: $60hr - $65hr

12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology. Activities Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement Ensures pre-executed test protocol has the necessary test data requirements to run the tests Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process Able to author Validation Plan and compile Validation Summary Report and generates RTM Reviews and ensures that the Operational Procedure for the application is ready Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM Prior experience in using tools like ALM, DMS and JIRA Good to have experience in implementing US-DSCSA. Single point of contact for Geo and functional specific scope of services related to system assurance and compliance role including CSA, Val SME and test management. Responsible for Geo and functional specific service quality, performance and customer satisfaction, demand management. Perform CSL roles such as CSA, Validation SME, and Test Manager as required by CSL QMS. Build and manage relationship with regional stakeholders including gathering and resolving feedback. Review system assurance and compliance deliverables and guide team on daily basis.