Validation Engineer

PSC Biotech • Denver, CO

4d

About The Position

We are hiring an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP and regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences
• 2–5 years of validation experience within the pharmaceutical, biotech, or medical device industries
• Strong knowledge of equipment and process validation in FDA -regulated environments
• Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations
• Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities
• Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports
• Strong analytical and problem -solving skills
• Excellent written and verbal communication abilities
• Strong time management and organizational skills
• Detail -oriented mindset with a commitment to maintaining high -quality standards
• Must be authorized to work in the US
• No C2C at this time

Responsibilities

• Perform validation of PLC logic and operational sequences across normal, abnormal, and emergency scenarios.
• Conduct end‑to‑end testing of SCADA system integrations, ensuring accurate process visualization, trending, and operator control functionality.
• Execute real‑time testing of sitewide system interactions, including signal communication between PLCs, SCADA platforms, and auxiliary equipment.
• Verify data logging capabilities and integration with the PI Historian to support batch reporting, audit trails, and regulatory compliance documentation.
• Assess network resilience by testing system redundancy, communication failover, and implementation of security and access‑control protocols.
• Ensure seamless integration and validation of manufacturing equipment and facility systems.
• Troubleshoot and resolve issues related to validated equipment and processes, implementing corrective and preventive actions (CAPA) as needed.
• Additional responsibilities as assigned to drive project success.

Benefits

• W2 positions include our medical and sick time benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level