Apply on Employer Site

Valspec · 23 hours ago

Equipment Validation Engineer

Raleigh, NC

Full-time

Onsite

Mid, Senior Level

3+ years exp

Valspec is a global provider of system validation and lifecycle services, focusing on commissioning and qualification for clients in the Life Sciences industry. The GMP Equipment Validation Engineer will support CQV activities for manufacturing and utility equipment, ensuring compliance with regulatory standards and effective communication with client teams.

Software

Growth Opportunities

No H1B

Responsibilities

Lead and execute CQV activities for GMP equipment including: Autoclaves, CIP/SIP systems, Bioreactors, Incubators, Freezers, Refrigerators, Centrifuges, Washers, Controlled temperature units, Environmental chambers, HVAC systems, Clean steam generators, WFI systems, Process tanks, Utility systems (compressed air, nitrogen, etc.)

Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports

Perform risk assessments and impact analyses to support validation strategy

Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines

Troubleshoot and resolve equipment and process issues during commissioning and qualification phases

Maintain compliance with cGMP, FDA, and other applicable regulatory requirements

Provide timely updates and communicate effectively with client stakeholders