GxP CSV Engineer for MES Validation

Orion Innovation; Bothell (WA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Orion Innovation is seeking a CSV Contractor to lead validation activities for GxP electronic systems within the manufacturing and clinical environments. You will collaborate with Business Owners, Technical Owners, and Quality to document and manage CSV deliverables across the validation lifecycle, ensuring compliance with 21 CFR Part 11 and related regulations.

The role emphasizes independent work, strong problem-solving, and effective communication across technical and non-technical

Qualifications

• Experience with cGMP, GXP, GAMP and SDLC; 21 CFR part 11 familiarity.
• Strong CSV documentation development: plans, requirements, specs, tests.
• Knowledge of MES validation and relevant regulatory guidelines.
• Ability to work with cross-functional teams and documentation systems.

Responsabilités

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

Connaissances

Communication

Teamwork

Regulatory knowledge

Pharma systems

ITSM (ServiceNow)

Veeva

Problem solving

CSV knowledge

MES/ERP knowledge

Formation

Bachelor's degree in life sciences or engineering/IT

Description du poste

Orion Innovation is seeking a CSV Contractor to lead validation activities for GxP electronic systems within the manufacturing and clinical environments. You will collaborate with Business Owners, Technical Owners, and Quality to document and manage CSV deliverables across the validation lifecycle, ensuring compliance with 21 CFR Part 11 and related regulations.

The role emphasizes independent work, strong problem-solving, and effective communication across technical and non-technical