Senior CSV & MES Validation Lead | GMP Life Sciences

Adryan; Bend (OR); On-site; USD 125,000 - 160,000; Full time

Job summary

Adryan is seeking a Senior CSV Lead / MES Validation Lead to join our Life Sciences consulting team in Oregon. You will be employed by Adryan and assigned to support a leading pharmaceutical CDMO in Oregon.

You will lead CSV activities for MES and related manufacturing systems, overseeing the full validation lifecycle and collaborating across Manufacturing, Automation, IT/OT, and Quality teams to ensure compliance with GMP and data integrity standards.

Qualifications

• 7+ years of CSV experience in pharma/biotech or regulated life sciences.
• Strong hands-on MES validation experience in GMP environments.
• Experience leading MES validation workstreams and delivering validation artifacts.

Responsibilities

• Lead CSV activities for MES and related manufacturing systems.
• Execute full validation lifecycle: planning, IQ/OQ/PQ, testing, documentation.
• Collaborate with Manufacturing, Automation, IT/OT, and Quality teams to ensure compliant solutions.

Skills

CSV validation

MES validation

GMP environment

Leadership

GAMP 5

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

PAS-X

PharmaSuite

Siemens Opcenter

Job description

Adryan is seeking a Senior CSV Lead / MES Validation Lead to join our Life Sciences consulting team in Oregon. You will be employed by Adryan and assigned to support a leading pharmaceutical CDMO in Oregon.

You will lead CSV activities for MES and related manufacturing systems, overseeing the full validation lifecycle and collaborating across Manufacturing, Automation, IT/OT, and Quality teams to ensure compliance with GMP and data integrity standards.