Senior CSV Lead/MES Validation Lead

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

Employment Type: Full-time / Consultant (Employed by Adryan)

About the company

Adryan is an international engineering and quality consultancy dedicated to the pharmaceutical and biotechnology industry. We support leading life-sciences organizations across Europe and the United States with specialized expertise in Commissioning & Qualification, Computer System Validation, Quality & Compliance, Engineering and Project Management.

For this assignment we are looking for a senior professional who can make an immediate impact, strengthen our delivery at our client and become an important part of our growing US project organization.

About the Role

Adryan is seeking an experienced Senior CSV Lead /MES Validation Lead to join our Life Sciences consulting team. In this role, you will be employed by Adryan and assigned to support a leading pharmaceutical CDMO in Oregon.

Responsibilities:

• Lead CSV activities for MES and related manufacturing systems.
• Execute the full validation lifecycle, including planning, risk assessments, IQ/OQ/PQ, testing, and documentation.
• Support MES implementations, upgrades, enhancements, and change control activities.
• Ensure compliance with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, Data Integrity (ALCOA+), and cGMP requirements.
• Collaborate with Manufacturing, Automation, Engineering, IT/OT, and Quality teams to deliver compliant system solutions.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
• 7+ years of CSV experience in the pharmaceutical, biotechnology, or regulated life sciences industry.
• Strong hands-on experience validating Manufacturing Execution Systems (MES) in a GMP environment.
• Experience leading MES validation workstreams and managing validation deliverables independently.
• Knowledge of enterprise MES platforms such as PAS-X, PharmaSuite, Siemens Opcenter, or similar is highly preferred.

Why Join Adryan?

• Join a growing Life Sciences consulting organization with projects across North America and Europe.
• Work on high-impact pharmaceutical manufacturing programs with leading industry clients.

Adryan is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by applicable federal, state, or local law.