Computer Systems Validation Engineer

Job Description

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

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

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together to form something truly special. When you decide to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

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

Work closely 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 to manage tasks and documentation (experience with Jira is a strong plus).

Requirements

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Computer Science, Information Systems, or a related field.

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) is preferred.

Exposure to or 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

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 Holiday

Education Assistance

Pet Insurance

Discounted Fitness/Gym Rates

Financial Perks and Discounts

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $80,000 - $110,000 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 applicant’s, employee’s, or intern’s 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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Full-time