Commissioning Qualification Validation Engineer

2 weeks ago

Atlanta, United States PSC Biotech Full time

Job DescriptionPSC 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 teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia-Pacific and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.The ExperienceWith 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, its about more than just a jobits about your career and your future.Your RoleWe are looking for a Commissioning, Qualification, and Validation (CQV) Engineer. The CQV Professional would work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape.Commission, qualify, and validate, GxP facilities, equipment, and utilities in assigned projects.Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.Draft and execute validation documentation such as:Validation Project & Master PlansRequirement Specifications (URS, DS, FS)IQ and OQ Test ScriptsIQ/OQ/PQ ProtocolsValidation Summary ReportInitiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.Conduct preventative maintenance and perform risk assessments.Recommended process improvements where needed ensuring compliance with industry standards.Establish validation standards and develop performance testing and quality control measures.Execute process equipment and clean room validation.Clearly communicate all progress, updates, and action steps for assigned projects.Collaborate with multiple departments on assigned project activities and deliverables.#J-18808-Ljbffr

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