GMP Asset Mechanic
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.
The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase, qualified and documented as needed, maintained and commissioned prior to use, and properly decommissioned and stored for future use. This individual reviews equipment and room designs, executes qualification and maintenance activities, troubleshoots and assesses failures and corrective work as well as implement applicable preventative actions, and provides input for the development of maintenance plans, tasks, procedures, and schedules. The individual recommends and/or procures spare parts and consumables. Individual will provide supervision of external contractors to maintain equipment while documenting historically significant activities as directed.
This individual coordinates the daily activities of a technical professional team including contractors. In addition this individual fosters a high level of knowledge and competence relating to equipment within the GMP Operations function by acting as a trainer and mentor. This includes refining and enforcing best practice maintenance, product adjustment and troubleshooting.
Performs planned and unplanned maintenance on assets in a GMP environment and ensures activities are properly documented.
Troubleshoot equipment and system failures and determines or supports determination of root cause and recommends/performs corrective actions and preventative measures.
Coordinates and performs equipment relocation and initial equipment setup / startup / commissioning per production schedule. Acts to prevent damage during relocation, that the asset is fully functional and within specification before releasing asset for use, and that operators understand equipment operation and status.
Supports installation of new equipment which may include: FAT, SAT, execution of qualification protocols, and determination of maintenance plans and spare parts
Work cross-functionally with other resources (operations, purchasing, planning, QA, Project Management, laboratory, manufacturing, etc.) to schedule, perform and properly document any and all relevant tasks pertaining to GMP Assets.
Utilizes and develops task lists and maintenance plans derived from experience, asset manuals, and review with manufacturer technical support regarding equipment commissioning, setup, operation, maintenance, and decommissioning.
Develops and performs; work orders, work permits, change controls, and writes, reviews and/or approves Standard Operating Procedures (SOPs), specifications, and other procedures as required.
Training of personnel regarding equipment maintenance, setup, operation, cleaning, SOPs, etc.
Follow Lonza safety procedures, participate in safety processes, and comply with all state and federal regulatory requirements and guidelines.
Provide input for forecasting of budget requirements and help to manage department expenses
Maintain a positive, professional, and confidential relationship with internal customers, clients, and vendors.
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
HS Diploma or GED
Strong working experience in GMP environment.
Ability to provide 24-hour emergency support as defined and perform other applicable duties as assigned.
Strong knowledge of Packaging Equipment
Solid experience coordinating daily activities of technical professional team.
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.