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 Tampa is seeking an Equipment Qualification Engineer who's responsibilities include but are not limited to: management of equipment qualification activities, development of qualification documents as well as the review and approval of qualification documents developed by others. The Equipment Qualification Engineer will also train and enhance the knowledge of system owners and subject matter experts in the development, application, and execution of equipment qualification including qualification of associated computerized systems.
Key Accountabilities:
Develop, lead development of, and manage efforts to qualify equipment and associated computerized system controls for new and modified process, utility, and support equipment as well as analytical instruments used in development and quality control
Review and update existing equipment qualifications and / or periodic reviews
Provide insight and direction to changes in regulatory and industry standards for equipment qualification, data integrity, and validation
Evaluate and update site equipment qualification governance procedures to ensure compliance with Regulatory requirements, Corporate Procedures, and Good Engineering Practices
Coach and develop system owners and subject matter experts in equipment and equipment skid system qualification processes
Assess and support site compliance with validation requirements for GxP computerized systems and applications per CFR 21 FDA Part 11, Annex 11 and EU GMP Annex 1
Represent Lonza Tampa as the site system owner for and maintain equipment qualification software (KNEAT)
Work with and review data collected in the site CMMS (SAP PM)
Perform Failure Mode and Risk Assessment analysis to ensure qualification plans are inclusive of potential critical and major concerns
Demonstrate knowledge of mechanical and control system operations to allow development and/or review of IQ, OQ, PQ, DQ and risk assessment protocols
Participate in projects targeted to expand site drug product capabilities and capacities to determine qualification requirements and resource needs
Demonstrate consummate writing and organizational skills to manage large and intertwined documents and multiple projects
Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
Stop work where deemed necessary to maintain safety
Key Requirements:
Bachelors degree in Mechanical Engineering
Minimum of 7 years' experience
Significant experience in cGMP pharmaceutical setting preferably oral solid dosage
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.