- Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies, clients and Lonza specifications/requirements.
- Assures that all validation documentation meets or exceeds the regulatory expectations.
- Highly experienced with equipment and/or computer system validation.
- Able to work with minimal assistance and supervision on validation discrepancies or investigations.
- Able to assess deviations that affect validation with minimal assistance.
- Able to lead change controls for new product/process equipment into the Lonza Houston facility and assess minor change controls with minimal assistance.
- Able to work with minimal assistance on moderate Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
- Experience with autoclaves and VHP systems.
- Able to speak in audits as a Validation SME.
- Perform other duties as assigned.
- BS/ BA in and Engineering or Life Science discipline.
- Five plus years of experience with validation lifecycles for computerized systems, aseptic processing, sterilization validation, and equipment/facility/utility validation.
- GMP compliance knowledge of 21CFR210, 211, 820, ISO 9001, 13485, EU Guidelines, and FDA Guidance on Aseptic Processing.
- Thorough understanding of industry standards, best practices for computer system validation, such as GAMP, FDA 21 CFR Part 11 compliance.
- Verbalize concisely and clearly to all levels, including upper management, customers, government auditors, peers and reports.
- Able to provide advice as validation subject matter expert and openly communicate any relevant issues.
- Demonstrated project management abilities to lead and manage projects.
- Ability to work in a fast paced environment.
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Senior Validation Engineer - Houston, United States - Lonza
Description
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and have an exciting opportunity to join our Houston, TX Quality Assurance team as a Senior Validation Engineer . The Senior Validation Engineer will support the Validation Manager by ensuring effective implementation and maintenance of the Validation program, Serve as a Validation subject matter expert (SME) and track/report action plan status/completion as it relates to validation systems improvement efforts and will be responsible for the writing of and the execution of project and system qualifications, validation, and re-qualifications/periodic reviews.
Key Responsibilities:
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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.
