Today Lonza is a global leader in life sciences. 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.
You will be overseeing the preventative & repair maintenance of production/utility systems, periodic inspections of utility systems to ensure proper operation, and daily checks/repairs in compliance with company and departmental Standard Operating Procedures (SOPs). Oversee the day-to-day operations of the Utility systems. You will maintain records to comply with Good Manufacturing Practice requirements. As clean utility systems SME, provide wide range of utilities systems audit supports and work closely with various quality and validation team actions such as CAPA, effectiveness monitoring, system review, deviations, audit observations etc. Individual will work in a fast-paced, safety-oriented, team focused setting. You take ownership of systems and helps to mentor other technicians on the operation and troubleshooting. Must be skilled, flexible, self reliant with a proven ability in facility environments.
- Oversee the performance of daily inspections of utility systems to ensure proper operation: Water for injection (WFI) Generation & Distribution, Water treatment system, Portable Water System, Pre-treatment Water System, Clean Steam Generation & Distribution such as CO2, N2, Process Gas, Compress Air, CIP-100 & 200 storage & transfer.
- Secondarily, oversees operation of fire water system, waste water, lab vacuum system and bulk solvent.
- Ensure safe, smooth utility plant operations by determining work priorities; scheduling repair/ maintenance of equipment for plant facilities and utilities services.
- Implement preventive maintenance programs by reviewing operations, quality control and maintenance reports and statistics; inspecting operating equipment and systems for conformance with operational standards/cGMP for utilities services.
- Support any project and commissioning of utility systems by reviewing new commissioning plans; discussing equipment needs and modifications with contractors/engineers/consultants; coordinating activities of utility technicians’ involvement.
- Manage contractors and vendors to ensure equipment is maintained in full operational status.
- Participate and lead, when required, in all investigations (contaminations, observations, deviations, and discrepancies) relating to the audit, manufacturing process and propose CAPA.
- Oversee deliveries of process gasses and supplies, pickup of chemical waste.
- Responsible for ensuring all GMP documentation related to maintenance activities is completed accurately and processed to full completion.
- Oversee the training of Utility Technicians to increase their knowledge of the utility systems
- Perform system evaluations and performance reports to ensure all utility equipment is operating efficiently and down time is limited to scheduled maintenance.
- Analyze technical problems in the utility and manufacturing areas and develop both short term and long term recommendations for their correction. Lead or assist cross-functional teams in finding solutions to technical problems
- Ensure always systems and facilities are comply to local and site regulatory requirements.
- Ensure facilities audit readiness and address facilities fitness deficiencies timely
- Degree/diploma in the relevant engineering discipline.
- Experience as a system SME/system owner in FDA regulated facility in a cGMP environment, semi-conductor or petrochemical industry.
- Must be proficient with respect to the operation and maintenance of various utility systems.
- Understand the design, installation, and maintenance of utilities system that supports a complex manufacturing plant.
- Knowledge of GMPs, FDA guidelines and process validation.
- Familiar with pharmacopoeia standards.
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.