Automation and Validation Engineer

Job description

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.

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.

Requirements Bachelors 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.

Benefits Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success.

We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

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 (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).

Financial Perks and Discounts 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.

Equal Opportunity Employment Statement: PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicants, employees, or interns actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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Bachelors Degree in Engineering or related discipline.


5+
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 for project assignments and client engagements across various regions.

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.

Required Skill Profession

Healthcare Practitioners And Technical