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Validation Engineer

2 months ago

Rockville, United States PSC Biotech Full time

Rockville, United States | Posted on 08/15/2024 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 multiple commissioning, qualification, and validation projects. Develop and execute IQ, OQ, PQ, and PV protocols, test methods, procedures, reports, risk assessments, and so on for a range of pharmaceutical and manufacturing equipment, facilities, utilities, and associated systems. Contribute to the development of master plans and validation strategies for a variety of manufacturing processes, adhering to regulatory requirements and compliance. Collaborate with cross-functional teams to ensure alignment and successful completion of validation activities and deliverables. Perform risk assessments and support risk mitigation strategies. Investigate, review, and efficiently close deviations. Provide support for regulatory inspections as needed. Identify potential risks/issues throughout validation lifecycle, effectively supporting change controls. Conduct periodic reviews and requalification assessments as needed. Ensure all required documentation is reviewed, approved, stored, and managed accurately. Collaborate with vendors and contractors to ensure that equipment and systems meet validation requirements and specifications. Drive continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization. Additional responsibilities as required to drive successful project completion. Requirements Bachelor's degree in relevant engineering discipline. 5+ years in an equipment commissioning, qualification, and validation engineering role, including proven success developing and executing validation protocols in the pharmaceutical manufacturing industry. In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc. Experienced with validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems. Advanced understanding of validation principles and methodologies. Excellent technical writing skills. 5+ years of experience drafting, developing, reviewing, and authoring technical documentation including protocols, procedures, risk assessments, specification requirements, etc. Strong understanding of engineering specifications (URS, DS, FS, etc.) Detail-oriented with a focus on accuracy and compliance. Ability to manage multiple priorities and prioritize tasks effectively. Excellent communication and interpersonal skills. Strong analytical skills with the ability to problem-solve and troubleshoot effectively. 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. Equal Opportunity Employment Statement: PSC 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. #J-18808-Ljbffr