Senior Quality Engineer

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 a motivated Senior Quality Engineer to join our team! The Senior Quality Engineer provides technical leadership across validation execution and Quality Management System (QMS) initiatives within regulated life sciences environments. This role supports GMP compliance while also contributing to QMS design, implementation, and certification readiness efforts. The Senior Quality Engineer partners with clients and internal stakeholders to deliver validation solutions, develop scalable quality systems, and support successful ISO certification outcomes. Lead and execute validation activities, including validation planning, protocol development, execution oversight, deviation management, and final reporting, in alignment with GMP and ISO principles. Ensure validation activities align with design specifications, process requirements, and regulatory expectations. Apply risk‑based thinking throughout validation and manufacturing activities to identify, assess, and mitigate quality and compliance risks. Mentor junior engineers and provide subject‑matter expertise on validation best practices and regulatory expectations. Support QMS design, implementation, and enhancement initiatives aligned with ISO requirements. Perform gap assessments against ISO clauses and develop remediation plans to support ISO compliance readiness. Contribute to development and maintenance of ISO‑aligned Quality Manuals and core SOPs Support ISO readiness activities including internal audits, audit preparation, and remediation tracking. Participate in or support internal auditor training activities to build sustainable client audit capabilities. Provide audit support during third‑party certification body audits, including document review, interview support, and response coordination. Assist with management review preparation by providing validation metrics, risk assessments, and continuous improvement recommendations. Requirements Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline. 7+ years experience in validation engineering within regulated industries such as pharmaceutical, biotechnology, or medical devices. Proven experience supporting QMS design, implementation, or enhancement aligned with ISO standards. Demonstrated understanding of ISO compliance readiness, gap assessments, internal audits, and certification processes. Strong working knowledge of core Quality Management System elements, including document control, risk management, supplier qualification, nonconformance/CAPA, and change management. Experience supporting or participating in internal audits and certification body (registrar) audits. Ability to apply risk‑based thinking across validation, manufacturing, and quality activities. Strong communication and stakeholder‑facing skills, with the ability to explain technical and regulatory concepts clearly. Ability to manage multiple priorities in a fast‑paced, consulting or project‑based environment. Must be authorized to work in the U.S. No C2C at this time. Benefits W2 Temp positions offer our medical and sick time benefits. Equal Opportunity Employment Statement PSC Biotech 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. #LI-RD1