CSV Consultant

Hobson Prior is seeking a CSV Consultant to join a highly automated pharmaceutical manufacturing facility in Oregon. This is a 12-month, fully onsite contract role with an immediate start. You will play a key role in supporting IT and operational technology systems that ensure the production of life-saving medicines. The position involves collaborating with cross-functional teams to maintain compliance, enhance systems, and support digital transformation initiatives.

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Review system documentation to ensure compliance with internal procedures and regulatory standards.
• Create and update validation plans, test reports, and other technical documents.
• Apply data integrity principles to quality management records.
• Investigate system deviations, identify root causes, and recommend corrective actions.
• Act as a subject matter expert during audits and inspections, ensuring timely completion of follow-up actions.
• Support system maintenance and enhancements while maintaining validated states.
• Conduct periodic system reviews and ensure audit readiness.
• Collaborate with local and global teams on validation and compliance activities.

Key Skills and Requirements:

• Background in computer science, engineering, life sciences, or a related field.
• Familiarity with IT and operational technology systems in regulated industries.
• Knowledge of regulatory standards such as FDA CFR 21 Part 11, EU GMP Annex 1, and GxP practices.
• Understanding of system risk assessments and data integrity principles.
• Strong communication skills and ability to work collaboratively in diverse teams.
• Experience with system administration, software development, or manufacturing control systems is a plus.
• Familiarity with tools like Veeva, HP ALM, Valgenesis, or ServiceNow is advantageous.

For more information, please contact Jack Keens .

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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