PSC Biotech® Corporation · 1 day ago
Validation Engineer
Denver, CO
Full-time
Onsite
Entry, Mid Level
2+ years expPSC Biotech® Corporation provides essential services to the life sciences sector, ensuring healthcare products meet regulatory standards. The Validation Engineer will support equipment, process, and facility validation activities in a regulated environment, focusing on compliance and product quality.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
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
Qualification
Required
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
Benefits
Medical and sick time benefits
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase