Software Validation Consultant for SAP Hana Project

This 6-month contract position is responsible for supporting SAP Hana Lift and Shift project, specifically in regard to the resultant system’s validation. This includes structure of validation documentation, training of personnel, monitoring of participant progress and report generation. The validation process and resultant documentation must be consistent with the requirements of global regulations and standards applicable to medical devices.

Essential Duties and Responsibilities:
• Structure validation documentation per requirements of supervisor and own suggestions
• Inventory and track requirements, test scripts, testing and documentation completion
• Drive completion of validation deliverables to program schedule
• Create validation and test script templates for teams to utilize
• Assure testing approach and documentation meet the requirements of applicable guidance documents (US FDA) and standards (ISO)
• Assure proposed testing provides appropriate coverage and challenge cases
• Support creation of required risk documentation, inclusive of FMEAs
• Consult on and recommend best practices related to validation of an SAP Hana
• Maintain bug list, with their relative risks, dispositions and closure for gaps identified during test

Qualifications:
• Bachelor’s degree in Information Technology, Software Engineering, Engineering, or related technical discipline
• Certifications in Software Validation, SAP and/or SAP Hana preferred
• Minimum of 5 years’ experience in the Medical Device, Pharmaceutical or similarly regulated industry
• Verifiable experience supporting SAP, or comparable enterprise system, and its migration or implementation, with measurable successes in the areas of validation and test
• Thorough understanding of cGMP, and ISO 13485 related to their requirements for the validation of Quality System software
• Ability to differentiate between QMS and non-QMS data in an enterprise system
• Capable of building consensus across functional areas
• Capability and confidence to lead cross-functional teams
• Determination to succeed in a complex and challenging environment
• Proficient in Microsoft Office and SAP

Knowledge/Skills/Abilities:
• Must have good written and oral communication skills
• Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail
• Knowledge of FDA and ISO standards for Medical Devices is a plus
• Ability to multi-task, perform efficiently, and independently

Working Condition:
• Open office environment
• Position will likely remain remote