Senior PAS-X MES Validation Lead | CSV Expert

USDM Life Sciences; Foster City (CA); On-site; USD 117,000 - 138,000; Full time

Job summary

USDM Life Sciences seeks a senior Validation Lead with 10+ years of CSV experience in a GxP pharma/biotech setting to lead Werum PAS-X MES validation across manufacturing and quality operations. You will own validation lifecycle documentation, drive IQ/OQ/PQ testing, and ensure audit-ready deliverables.

Collaborate with Werum, IT, QA, and regulatory affairs to meet 21 CFR Part 11 and EU GMP Annex 11; manage PAS-X integrations with SAP ERP, DCS/SCADA, and LIMS; mentor junior engineers and

Qualifications

• Minimum 10 years of CSV within GxP pharma/biotech/medical device environments.
• Experience validating Werum PAS-X MES including eBR, process order, material management, and genealogy.
• Deep knowledge of GxP regulatory requirements (21 CFR Part 11, EU GMP Annex 11, GAMP 5, ICH Q10).
• Experience authoring/executing IQ, OQ, PQ, validation plans, RTMs, and summaries.

Responsibilities

• Lead Werum PAS-X MES validation activities across manufacturing and quality operations.
• Author, review, and approve Validation Master Plans, URS, FDS, CS, and IQ/OQ/PQ reports.
• Lead IQ, OQ, PQ validation testing, manage testers, resolve deviations, ensure audit-ready documentation.
• Collaborate with Werum, IT, quality, manufacturing, and regulatory teams to ensure PAS-X configurations meet GxP requirements.
• Oversee validation of PAS-X eBR, process orders, material management, genealogy, and reporting functionalities.
• Manage PAS-X integration validation with SAP ERP, DCS/SCADA, and LIMS.
• Support 21 CFR Part 11 compliance assessments and audit readiness during inspections.
• Develop RTMs linking requirements to design, tests, and evidence; maintain validation status reporting.
• Mentor junior validation engineers and contribute to site validation procedures and templates.

Skills

PAS-X MES

CSV lifecycle

GxP knowledge

IQ/OQ/PQ

eBR

Regulatory audits

Cross-functional lead

SAP integration

Education

Bachelor's degree in Life Sciences, Pharmacy, Biochemistry, Chemical Engineering, Information Systems, or related

Job description

USDM Life Sciences seeks a senior Validation Lead with 10+ years of CSV experience in a GxP pharma/biotech setting to lead Werum PAS-X MES validation across manufacturing and quality operations. You will own validation lifecycle documentation, drive IQ/OQ/PQ testing, and ensure audit-ready deliverables.

Collaborate with Werum, IT, QA, and regulatory affairs to meet 21 CFR Part 11 and EU GMP Annex 11; manage PAS-X integrations with SAP ERP, DCS/SCADA, and LIMS; mentor junior engineers and