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 in an effort to form something truly special. When you make the decision 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

We are hiring an experienced Validation Engineer to support equipment, process, software, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP, Annex 11, and global regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.

• Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems.
• Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements.
• Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification.
• Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity.
• Validate and qualify various equipment and utilities i.e Depyrogenation Ovens
• Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed.
• Maintain accurate validation documentation and ensure audit readiness.
• Additional responsibilities as assigned to drive project success.

Requirements

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 $90,000 to $125,000 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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field. Proven experience in equipment commissioning, qualification, and validation engineering experience in the pharmaceutical manufacturing industry. Strong knowledge of regulatory requirements and industry standards.Strong understanding of risk-based validation and full life cycle approach. Experience qualifying large process equipment and supporting utilities (i.e. vessels, CIP / SIP skids, isolators, autoclaves, WFI, clean steam, etc.) Cell and gene therapy experience preferred. Experienced with paperless validation systems, i.e. Kneat Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance. 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