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 looking to hire a Packaging Process Engineer to ensure that all GMP Manufacturing processes are designed and executed in a compliant and efficient manner. The Packaging Process Engineer is involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Packaging Process Engineer works cross-functionally within the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Lonza.
Key Accountabilities:
Provide technical support to all GMP packaging processes and projects
Write Master Batch Records and review executed batch records
Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required
Recommend, specify and order GMP packaging equipment which includes setup, qualification, writing and execution of qualification protocols
Process validation of commercial packaging processes including writing, review and execution of process validation protocols
Participate in project scheduling (including daily, short term, and long term) activities along with all applicable departments
Provide input for forecasting of budget requirements and help to manage department expenses
Collaborate with maintenance personnel for equipment installation, facilities equipment repair and preventative maintenance
Execute various duties to support change requests, deviations, investigations, CAPA’s, and operational improvement programs
Maintain a positive, professional and confidential relationship with sponsors
Comply with all state and federal regulatory requirements and guidelines
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:
BS degree in Engineering strongly preferred; Extensive experience may substitute for educational requirements.
Ability to identify problems, collect data, and establish facts and discuss possible solutions.
Ability to follow technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to work on multiple projects and meet all project deadlines as needed.
Communicate with supervisor on status of projects daily required.
Strong written, presentation, and oral communication skills required.
Strong ability to read and interpret technical documents such as Operations manuals, Master Batch Records, Protocols, Standard Operating Procedures. Strong technical writing ability required in order to produce routine reports, equipment qualification protocols, master batch records, etc. Ability to speak effectively before groups.
Strong mathematical and computer skills.
Minimum Years Required Experience: 3
Preferred Field of Experience: Pharma cGMP
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.