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CSV Engineer I
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.
Job SummaryWe are seeking an entry-level CSV Engineer to join our team in a remote position. As a CSV Engineer, you will be responsible for providing test script development and execution, traceability matrix generation, and execution of CSV protocols. You will also generate and execute validation documents, provide support in a variety of CSV tasks, and participate in computer system validation project activities.
Key Responsibilities- Develop and execute test scripts for IQ, OQ, and PQ validation
- Generate and execute traceability matrices
- Perform execution of CSV protocols
- Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT)
- Provide support in a variety of CSV tasks
- Participate in computer system validation project activities
- Initiate and oversee system CSV associated change control requests and associated validation documentation
- Author, review, and approve scheduled periodic reviews
- Participate in computer validation project activities and create computer system planning documents and testing protocols
- Review test results and identify areas of improvement to implement changes
- Review and modify Standard Operating Procedures (SOPs)
- Review and analyze validation data – compiling reports when required
- 0-6 months of experience developing and executing IQ, OQ, PQ test scripts
- CSV experience preferred
- Veeva Vault system experience preferred
- Effective written and oral communication skills
- Excellent time management, interpersonal, and problem-solving skills
- Strong attention to detail
- Willingness to travel is preferred
PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance. We also offer a range of other benefits, including pet insurance, discounted gym memberships, and financial perks.
Equal Opportunity Employment StatementPSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, hiring, 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.
