Computer Systems Validation Engineer

ZipRecruiter; Santa Ana (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in the life sciences sector is seeking a dedicated professional to join their team. This role involves ensuring compliance with regulatory standards through thorough validation processes and documentation. You will collaborate with diverse teams to support system requirements and deliver compliant solutions. The company values professional growth and offers a comprehensive benefits package, including health insurance and a 401(k) plan. If you're passionate about making a difference in healthcare and enjoy working in a dynamic environment, this opportunity is perfect for you.

Benefits

Medical, Dental, and Vision Insurance

401(k) Plan with Matching Contributions

PTO and Sick Leave

Educational Assistance

Pet Insurance

Discounted Gym Rates

Qualifications

• 3+ years of experience in computer system validation in a GxP environment.
• Familiarity with pharmaceutical manufacturing or laboratory equipment.

Responsibilities

• Author and review CSV documentation to meet quality standards.
• Conduct GxP assessments for computerized systems and ensure compliance.

Skills

Computer System Validation (CSV)

GxP Compliance

Strong Communication Skills

Pharmaceutical Industry Experience

Education

Bachelor's Degree in Chemical Engineering

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Computer Science

Bachelor's Degree in Information Systems

Tools

Jira

LIMS

HPLC

UV-VIS

Job description

Job Description

PSC Biotech provides the life sciences industry with essential services to ensure that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to accelerate our clients’ success, and you can be part of our team’s achievements. Employing a global team of skilled professionals and experts across North America, Europe, Asia, and the Middle East, we are proud of the roles we have fulfilled to help our clients succeed.

The Experience

With operations worldwide and a multicultural team, PSC Biotech is passionate about bringing together talented individuals to create something exceptional. Joining our team offers you the opportunity to be inspired in your career, explore your professional passions, and work alongside colleagues who value and nurture your talents.

We believe in coaching and developing future industry leaders and influencers. Therefore, we offer competitive compensation and benefits, along with tools to support your growth and learning.

At PSC Biotech, it’s about more than just a job—it’s about your career and future.

Your Role

• Author, review, and approve CSV documentation to meet quality standards and regulatory requirements.
• Conduct GxP and risk assessments for computerized systems.
• Perform scheduled periodic reviews to ensure ongoing system compliance.
• Develop and maintain IT SOPs related to system compliance and validation.
• Collaborate with project stakeholders and IT teams to gather system requirements and deliver compliant solutions.
• Create validation deliverables including Validation Plans, URS, Design and Functional Specs, IQ/OQ protocols, Traceability Matrices, and Validation Summary Reports.
• Utilize Jira or similar systems for task and documentation management (experience with Jira is a strong plus).

Requirements

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Computer Science, Information Systems, or a related field.
• At least 3 years of experience in computer system validation (CSV), preferably in a GxP-regulated environment.
• Familiarity with pharmaceutical manufacturing or laboratory equipment (e.g., HPLC, UV-VIS).
• Experience with paperless validation systems and/or LIMS is a plus.
• Strong written and verbal communication skills.
• Experience working in the pharmaceutical, biotech, or medical device industry.
• Prior involvement with DeltaV systems or integrated manufacturing equipment is a bonus.

Benefits

PSC Biotech offers a comprehensive benefits package aimed at promoting work-life balance and employee well-being, including:

• Medical, Dental, and Vision insurance (PSC covers 100% of employee premiums and 50% for dependents)
• Insurance options including Employee Assistance Programs, Life Insurance, Short/Long Term Disability, and more
• 401(k) plan with matching contributions
• PTO, Sick Leave, and Paid Holidays
• Educational Assistance
• Pet Insurance
• Discounted Gym and Fitness Rates
• Financial Perks and Discounts

The salary range for this role is $80,000 - $110,000 annually, depending on qualifications, skills, and experience, in accordance with California's salary transparency law.

Equal Opportunity Employment

PSC is committed to Equal Employment Opportunity and complies with all applicable laws regarding employment discrimination. We prohibit discrimination based on race, color, religion, sex, national origin, age, genetic information, disability, or any other protected status.

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