Lead quality assurance, business process validation, and end‑user readiness for SAP solutions and related enterprise applications.
Responsibilities
Develop risk‑based test strategies, plans, schedules, and governance for SAP and connected enterprise applications
Coordinate testing across the software lifecycle, including functional, integration, regression, user acceptance, and end‑to‑end business process testing
Translate business requirements and process designs into test scenarios, scripts, acceptance criteria, and traceability records
Oversee test preparation and execution, including test data, environments, defect logging, triage, retesting, and readiness reporting
Work with process owners and subject matter experts to validate that SAP solutions support operational needs and defined business controls
Validate data integration and automation solutions to ensure data quality, system integrity, and regulatory compliance for clinical and business operations.
Responsibilities
Validation planning, strategy & readiness
Perform data integrity and consistency checks across data pipelines, integrations, and automation workflows
Test execution, defect management, & issue resolution
Execute standard and study-specific validation tests in alignment with established protocols and test scripts
Log, track, and retest defects in accordance with defect management procedures and timelines
Requirements
Non-Degree with a minimum of 2 years of experience
Associate's Degree with a minimum of 1 year experience
Bachelor's Degree or Advanced Degree (Masters or Doctorate)
A technical specialist who owns the Distributed Control System (DCS) lifecycle and understands the complexities of biopharmaceutical manufacturing, bridging the gap between process engineering, quality control, and automated software workflows.
Responsibilities
Oversee daily operation, continuous maintenance, and system lifecycle of Siemens PCS7, PLCs, and SCADA platforms across GMP manufacturing suites.
Manage hardware and software upgrades, patches, and system expansion to support changing manufacturing requirements.
Maintain system backups, disaster recovery protocols, and business continuity planning for all plant floor automation assets.
Lead, mentor, and develop a high-performing team of automation engineers, system administrators, and third-party system integrators.
Oversee resource scheduling to ensure uninterrupted 24/7 technical and plant floor troubleshooting support for active GMP manufacturing campaigns.
The Solution Manager for Clinical Operations serves as the technology delivery partner for one or more clinical solutions supporting key business capabilities across Lilly’s trials. Working within established strategy and roadmaps, this role drives delivery and service excellence and ensures solutions are compliant, scalable, and aligned with business priorities.
Compensation
The anticipated wage for this position is $129,000 - $189,200
Responsibilities
Partner with Clinical Operations stakeholders to translate solution strategy and roadmaps into delivery plans and measurable outcomes for assigned solutions.
Own the end-to-end lifecycle of assigned solutions, including delivery, validation, service transition, operations, and continuous improvement.
Lead cross-functional delivery with business, quality, security, architecture, and vendor partners to ensure solutions are compliant, scalable, and fit for purpose.
Manage operational health through governance, issue resolution, service performance, risk management, and day-to-day vendor oversight.
Support investment and prioritization decisions by building business cases, evaluating trade-offs, and balancing value, cost, and risk.
Consultant role focused on Digital Risk within Consumer Products and Healthcare sectors, specializing in computer system validation (CSV) and GxP compliance.
Responsibilities
Perform computer system validation (CSV) across the system lifecycle
Conduct requirements, risk assessment, testing, and validation documentation
Work with 21 CFR Part 11 requirements for electronic records and electronic signatures
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Identify gaps in system controls and recommend remediation approaches
Consultant in Business Consulting Risk focusing on digital risk and enterprise risk management.
Responsibilities
Proven experience in computer system validation (CSV) across the system lifecycle, including requirements, risk assessment, testing, and validation documentation.
Working knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures, including audit trails, access controls, and data integrity.
Skilled in preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices.
Familiar with GxP-regulated computerized systems and the compliance expectations of regulatory inspections and audits.
Capable of identifying gaps in system controls and recommending remediation approaches that align with regulatory and industry standards.
Consultant in Business Consulting Risk focusing on Enterprise, Technology, and Financial Services Risk within the CHS Consumer Products and Healthcare sectors.
Responsibilities
Identify and manage risk in client businesses
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols
Recommend remediation approaches for system controls
Collaborate across client departments to deliver solutions
Consultant in Business Consulting Risk focusing on Enterprise, Technology, and Financial Services Risk within the CHS Consumer Products and Healthcare sectors.
Responsibilities
Identify and manage risk in client businesses
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols
Recommend remediation approaches for system controls
Collaborate across client departments to deliver solutions
Consultant role within Business Consulting Risk focusing on Digital Risk for Consumer Products and Healthcare sectors (CHS).
Responsibilities
Technical Excellence: performing computer system validation (CSV) across the system lifecycle, including requirements, risk assessment, testing, and validation documentation.
Working knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures, including audit trails, access controls, and data integrity.
Preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices.
Familiarity with GxP-regulated computerized systems and the compliance expectations of regulatory inspections and audits.
Identifying gaps in system controls and recommending remediation approaches that align with regulatory and industry standards.
TEST AND TRAINING MANAGERKMC Solutions, Inc. · Philippines
Business System Validation Associate SpecialistMSD · Warsaw, Poland
Assoc Director -Solution Delivery Management, Clinical OperationsLilly · Indianapolis, US
Consultant - Business Consulting Risk - CHS - CNS - Risk - Digital Risk - GurgaonEY · Gurugram, India