Automation and Validation Engineer

Position Overview

At PSC Biotech, we provide the life sciences industry with expert engineering, technical, and consulting services that drive operational excellence, ensure regulatory compliance, and enhance productivity. We are seeking a skilled Validation Engineer with hands-on experience in building automation systems and facility validation within GxP-regulated environments. This role focuses on the commissioning, qualification, and validation (CQV) of computerized systems and facility equipment—including HVAC, clean utilities, and environmental controls—across pharmaceutical warehouses, laboratories, and production spaces.

Key Responsibilities

• Support and execute the validation lifecycle for GxP computerized systems, utilities, and facility equipment.
• Author and review CSV documentation, including URS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
• Utilize building automation platforms (e.g., Siemens Desigo) to track facility conditions, equipment alarms, and system performance.
• Coordinate CQV activities for HVAC, plumbing, clean utilities, and environmental monitoring systems.
• Manage change controls, deviations, and CAPAs related to facility systems and automation platforms.
• Collaborate with cross-functional teams, vendors, and contractors to ensure alignment with project timelines and regulatory expectations.
• Provide technical guidance during audits and inspections, ensuring documentation and systems meet compliance standards.

Required Qualifications

• Bachelor’s degree in engineering or a related technical discipline.
• 5+ years of experience in validation engineering, with emphasis on facility systems and building automation in the pharmaceutical/life science industry.
• Proficiency in Siemens Desigo or similar building management systems.
• Strong understanding of GAMP 5, 21 CFR Part 11, and GxP compliance.
• Experience with both software and hardware validation activities.
• Excellent technical writing, communication, and project coordination skills.
• Willingness to travel as needed for project assignments and client engagements.

Benefits & Perks

Compensation: $100,000 - $130,000 annually (salary may be adjusted based on qualifications, skills, and professional experience).

• Medical, Dental, and Vision – PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
• 401(k) and 401(k) matching.
• PTO, Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Fitness Benefits, including membership discounts and perks at qualifying gyms.
• Financial Perks and Discounts.