Senior Validation Engineer

PSC Biotech • San Diego, CA

6d • $100,000 - $130,000

About The Position

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.

Your Role

We are seeking a skilled Validation Engineer with hands-on experience in building automation systems and facility validation within GxP-regulated environments. This role 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. The ideal candidate 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.

Requirements

• 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.
• Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Must be authorized to work in the US.
• No C2C at this time.

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.

Benefits

• W2 temp positions include our medical and sick time benefits.
• Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 - $130,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 51-100 employees