MES Validation Engineer - CSV Specialist

Socket.dev; Olympia (WA); On-site; USD 110,000 - 170,000; Full time

Job summary

Orion Innovation is seeking a CSV Contractor to lead validation activities for MES and other GxP systems within a regulated manufacturing environment. You will create and manage validation deliverables across the lifecycle, ensuring adherence to 21 CFR Part 11 and GAMP guidelines.

The role requires strong communication with technical and non-technical stakeholders, collaboration with Quality, and the ability to work independently in a fast-paced, global setting.

Qualifications

• 4+ years of CSV experience with GAMP/risk-based validation.
• Strong knowledge of CSV documentation (plans, requirements, specs, IQ/OQ/PQ).
• Experience validating MES and electronic records/signatures.

Responsibilities

• Author, review and/or approve CSV documentation.
• Assist owners during test execution; document failures and ensure alignment with procedures.
• Develop requirements and specifications for computerized systems used in GxP operations.
• Other related duties as assigned.

Skills

MES experience

GxP knowledge

Regulatory compliance

IT service management

Education

Bachelor's degree in life sciences or engineering

Tools

ServiceNow

Veeva

SAP/Oracle

InfoBatch

Emerson Syncade

Job description

Orion Innovation is seeking a CSV Contractor to lead validation activities for MES and other GxP systems within a regulated manufacturing environment. You will create and manage validation deliverables across the lifecycle, ensuring adherence to 21 CFR Part 11 and GAMP guidelines.

The role requires strong communication with technical and non-technical stakeholders, collaboration with Quality, and the ability to work independently in a fast-paced, global setting.