Validation Engineer IV
Lonza, Inc. Houston, TX
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Validation Engineer IV Job Summary: Support the Validation area Sr Manager by ensuring effective implementation and maintenance of the CSV program. Serve as a CSV subject matter expert, and track and report action plan status/ completion as relates to validation systems improvement efforts. Responsible for the writing of and the execution of project and system qualifications, validation, re-qualifications, and revalidation for Computer System Validation (CSV) Job Responsibilities: Documents User Requirements, Design Specification, Configuration Specification, Requirements Traceability. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, and 11 requirements, GAMP, among others. Performs periodic reviews and ongoing support of validated systems post Go-Live. Responsible for protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports. Works with Gap Assessments and Remediation Plans with an understanding of applying risk management principles. Supports regulatory and client audits as CSV subject matter expert. Provide CSV for cGMP documents including, but not limited to, SOPs, batch records, validation protocols and reports. Education and Experince Required: BS degree or equivalent in technical area preferred. 10-12 years’ experience in pharmaceutical, biotechnology, or related industry. Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others. GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, and 11 requirements, GAMP 5, ISO 13485:2003, among others. Skills Preffered: Excellent written and oral communication to include accurate and legible documentation skills. ability to work in a fast-paced environment. team oriented. independent work skills and a strong work ethic. The ability to interface and communicate directly with clients may be required. Microsoft Office and database management skills,. organization skills. record keeping skills. ability to handle multiple projects. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.