Responsible for oversight of Validation & Verification activities for a large and complex ERP transformation project. Support GxP quality computer software implementation. Ensure the SAP ERP system complies with global regulatory requirements regarding GMP computerized system validation compliance and data integrity and work with vendors to ensure systems are configured and validated properly. Coordinate and communicate between V&V team and other departments and SMEs. Partner with and/or leads Business Teams and cross functional teams to ensure that computerized quality systems (specifically SAP S/4 HANA) are compliant with Insulet corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5. Create and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, IQ Protocols, PQ Protocols, Test Protocols, Test Reports, test scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Lead the review and approval of validation deliverables. Ensure that all validation deliverables are prepared accordingly. Support Business Owners and cross functional teams in the definition and creation of Business Requirements, Functional Specifications and System Specifications. Communicate project and compliance issues to Quality Systems management and provide solutions to mitigate potential risks. Fulfill duties in accordance with requirements of the QSR regulations, ISPE GAMP 5 , Insulet corporate policies and procedures. Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
The position is fixed based in Acton, MA; however, telecommuting permitted up to 100%.
40 hours/week, 9:00am-5:00pm
Seven (7) years of experience as a Software Quality Assurance Engineer or a related occupation in the life sciences industry. Experience must include:

Seven (7) years of experience in the following (experience may be gained concurrently):
- Supporting GxP computer system validation efforts including authoring computer system validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports;
- Experience in change management, GxPs, 21 CFR Part 11/Annex 11, GxP 21 CFR part 820, and related regulations and guidance;
- Understanding of software development methodologies and concepts;
- Using MS Office suite.

Three (3) years of experience in the following (experience may be gained concurrently):
- supporting regulatory inspections and audits.

Two (2) years of experience in the following (experience may be gained concurrently):
- Supporting computer system validation (CSV) efforts for SAP S.4 HANA ERP system used in GMP, GLP, or GCP processes;
- Validating global ERP system (SAP).
Requires a Bachelors degree (or foreign equivalent) in Computer Science, Chemistry, Pharmacology, or any closely related STEM field

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