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Commissioning Qualification Validation Specialist
2 months ago
PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. Our team of experts spans the globe, with offices in North America, Europe, Asia-Pacific, and the Middle East. We are passionate about bringing together the best and brightest professionals to form a truly special team. As a Commissioning, Qualification, and Validation (CQV) Engineer, you will play a critical role in our mission to help our clients achieve success. Your responsibilities will include commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects. You will be responsible for protocol writing and execution, including drafting, executing, reviewing, and approving validation documentation to ensure compliance with cGMP requirements, regulatory requirements, and quality standards. You will also be responsible for initiating and coordinating risk analyses, design reviews, and executing FAT/SAT, IQ, OQ, and PQ. Additionally, you will conduct preventative maintenance and perform risk assessments, recommend process improvements, establish validation standards, and develop performance testing and quality control measures. You will work closely with multiple departments on assigned project activities and deliverables. If you have a Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience, and 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within a GMP environment, we encourage you to apply. You will be expected to have sound industry knowledge, project proficiency, and autonomy. You will also be expected to have experience in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc. You will understand current risk-based validation approaches and have experience in authoring, revising, reviewing, and completing controlled documents for validation projects. You will also have experience with system impact assessment and risk assessment. You will have good knowledge of the code of GMP and PIC/S code. Previous experience in the Life Sciences Industry and GxP Industries is required. You will be adaptable, customer service oriented, have a positive attitude, excellent organizational skills, high attention to detail, and strong written and verbal communication skills. We offer a competitive compensation and benefits structure that rewards you, as well as the tools to help you grow and learn. We are committed to a policy of Equal Employment Opportunity and prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment. We are an equal opportunity employer and welcome applications from diverse candidates.
