Summary & Key Responsibilities:

Develop system development life cycle documents related to global ERP system. This includes system specification documents, validation plans and test protocols, and procedures. Work with regional project teams to ensure global validation strategy is understood and followed. Develop development programming standards as needed.

1. Act as Validation Lead as assigned for Global US Implementation or Region for Global ERP.

2. Generate Validation Plan, Infrastructure Master Plan, Qualification Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix, as needed.

3. Participate in and guide team in generating User Requirements, Functional and Design Specifications. Provide guidance in generation of hardware system specifications.

4. Gain understanding and follow defined SDLC. Ensure quality validation processes are executed as defined by procedures.

5. Using risk-based approach to validation, determine testing, documentation and verification activities, with appropriate justification of the approach.

6. With team, develop validation strategy for components/workstreams that comprise the ERP system. Deploy strategy, defining documentation requirements and hierarchy for integrated system.

7. Manage electronic routing of required documentation*ensuring compliance to current procedure for e-approval.

8. Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project.

9. Manage validation team*coordinating documentation and testing. Generate test scripts, as needed. Execute testing as required.

10. Collaborate with business, quality, and technical individuals throughout project in generation of project / validation required deliverables.

11. Prepare validation package for archival.

12. Develop SDLC documents for global ERP system

13. Proficient in the various testing phases such as Manual Testing, GUI Testing, Functionality Testing, Security Testing, System Testing, Regression Testing, Integration Testing, Performance/Stress Testing, User Acceptance Testing, Back End Testing

14. Knowledge of testing tools like TestDirector, WinRunner, LoadRunner, Rational RequisitePro, Rational TestManager, Rational Robot, Rational ClearQuest, RUP, Rational SoDA for Word, SilkTest

Job Requirements:

1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business.

2. Highly skilled in Computerized System testing and validation in the healthcare industry. At least 5-7 years validation experience in both infrastructure qualification and application validation.

3. Proven results in managing validation aspect of software / infrastructure project implementation.

4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211, 820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.

5. Experience with use/control of Electronic Records/Electronic Signatures and electronic submissions to regulatory agencies.

6. Strong technical background--both from an application and infrastructure perspective.

7. Experience working in a highly regulated environment; GxP, QSR framework preferred.

8. Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.

9. Excellent communication including written, verbal, and listening skills.

10. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.

11. Knowledge of ERP or SAP system function, business use and validation.

Please Contact:

Curt Winkle

847-995-9200

[email protected]