Senior Validation 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 RoleWe are hiring an experienced Senior Validation Engineer. In this role you will be responsible for drafting, executing, and reviewing validation protocols with adherence to quality and compliance standards. A strong candidate will demonstrate exceptional attention to detail, rigorous documentation practices, and effective collaboration across cross-functional teamsExecute validation protocols for equipment, systems, and processes in compliance with regulatory and internal quality standardsPrepare and maintain validation documentation including protocols, reports, and standard operating procedures (SOPs)Collect and analyze data during qualification activities to support validation conclusionsIdentify and document deviations and assist in resolution and corrective actionsEnsure validation activities are completed according to established schedules and project timelinesCollaborate with cross-functional teams including quality, engineering, and operations to align on validation deliverablesMaintain audit-ready documentation and support internal and external inspectionsSupport change control assessments and evaluate the impact of changes on validated systemsParticipate in continuous improvement initiatives to enhance validation processes and documentation practicesEnsure adherence to cGMP, FDA, EMA, and other applicable regulatory requirementsRequirements7 years of hands-on experience in validation roles across pharmaceutical and biopharmaceutical environmentsStrong commitment to quality assurance and precision in executionExtensive knowledge of validation processes and lifecycle managementThorough understanding of global regulatory frameworksProficient in navigating quality systemsEffective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance.Preferred experience in Validation Lifecycle Management Platforms and QMS'sAt 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 are 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 timeBenefitsOffering 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 Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 to $130,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.Equal Opportunity Employment StatementPSC 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.#LI-TP1

Salary : $84,400 - $103,700