CQV 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

CQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients’ success.

• Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.
• Develop and execute IQ / OQ / PQ protocols for newly installed systems and equipment.
• Prepare and maintain documentation, including validation protocols, plans, reports, and standard operating procedures.
• Support risk assessments and mitigation strategies related to CQV activities.
• Troubleshoot and assist in resolving issues related to equipment and process performance.
• Collaborate with cross-functional teams to align CQV activities with construction and project timelines.
• Coordinate with vendors and contractors to support hand-offs and system turnover.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
• Provide technical support during validation execution and qualification activities.
• Additional responsibilities as required.

Requirements

Benefits

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 – $120,000 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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Requirements

Bachelor’s degree in engineering or a related field. 5+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and / or biotech industries. Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup. Strong background in cleanroom facilities, process equipment, and utility systems. Familiarity with project execution and project management tools. Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA). Knowledge of validation lifecycle and risk-based approaches. Excellent analytical and technical problem-solving skills. Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.). Effective communication and interpersonal skills. Organized, proactive, and detail-oriented with a commitment to quality and compliance. Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. We value candidates who are willing and able to travel as needed for project assignments and client engagements. Adaptability to different locations, cultures, and work environments is essential for successful collaboration.