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 CSV Engineer with hands-on experience in building automation systems and facility validation within GxP-regulated environments. In this role, you will focus 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. You will leverage tools like Siemens Desigo to monitor and manage facility performance, support system integration, and ensure compliance with GAMP 5 and 21 CFR Part 11 standards.

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 to ensure 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 required for project assignments and client engagements.
• Must be authorized to work in the US.
• No C2C at this time.

Benefits & Perks

• Medical, Dental, and Vision – PSC pays 100% of qualifying employee premiums and 50% for qualifying dependents.
• Insurance options including 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 – Membership discounts and perks at gyms such as Anytime Fitness and 24-Hour Fitness.
• Financial Perks and Discounts.

Compensation

Adhering to California’s salary transparency law, the salary bracket for this role is set between $100,000 - $130,000 annually. The offered salary may be adjusted based on the applicant's qualifications, skills, and professional experience.

Equal Opportunity Employment

PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. We comply with all applicable federal, state, and local laws concerning employment discrimination, and prohibit discrimination in all aspects of employment. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law.