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MilliporeSigma · 4 hours ago

Software Validation Engineer

St Louis, MO

Full-time

Hybrid

Senior Level

$67K/yr - $109K/yr

5+ years exp

MilliporeSigma is a company focused on innovating with science and technology to enrich lives in various sectors including Healthcare and Life Science. The Software Validation Engineer will guide validation projects for digital products and computerized systems, ensuring compliance with regulatory guidelines and leading qualification processes.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

Lead the qualification and validation of diverse digital products, computerized systems, and software solutions, including Control Systems, Cloud-based solutions, and Operational Technology (OT)

Execute the full validation lifecycle (IQ, OQ, PQ, protocols, test scripts, infrastructure qualification, backup/restoration, and audit trail testing) in both GMP and Non-GMP environments

Ensure compliance with global regulatory guidelines including GAMP, QMS, 21 CFR Part 11, and Annex 11

Perform critical assessments (Risk, Functional Risk, Data Integrity, FMEA) to define requirements and controls prior to development and verify tested systems meet those standards

Review and approve validation documentation, including URS, Functional/Design Specifications, and Test Scripts for COTS and new products

Develop and manage core validation documents, such as Test Scripts/Protocols, Test Summary Reports, Traceability Matrices, and Validation Summary Reports

Manage quality system activities, including Operational Change Control, Deviation/CAPA management, customer complaint handling, and periodic review/re-validation

Act as the validation expert during audits, effectively presenting and explaining qualification documents and reports to regulatory agencies, internal/external auditors, and customers

This is a hybrid role including 3 days on-site and 2 days remote work