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 Kingston is hiring a Operations Engineer. In this position you will be responsible for providing engineering solutions, identifying, sourcing, and bridging new and existing manufacturing technologies that can create efficiencies of scale. You will be responsible for process design and manufacturing process optimization. This is a hands-on position where you will be expected to identify requirements and source equipment and develop metrics for evaluating technologies. You will lead the facility’s calibration/maintenance program by performing, coordinating and documenting instrument calibrations and maintenance activities while assuring strict adherence to ISO and cGMP requirements. You will be expected to work in a high performing, cross-functional team with the goal of driving innovation in the development of scalable processes related to the manufacture of high end laboratory medical equipment and Single-Use-Products.
- Support the design, procurement and delivery of automation, fixtures and tooling to support product manufacturing and operational excellence execution
- Support all manufacturing equipment and process qualification activities while working closely with the MSAT department.
- Perform continuous improvement actions to ensure process reliability and COGS reduction targets
- Support manufacturing process planning
- Initiate actions to prevent the occurrence of any nonconformance relating to products or processes
- Complete/Coordinate the completion of associated cGMP production documentation including drawings, design specifications, acceptance testing, batch records, SOPs, PFMEA, Non-Conformances, ECN, etc.
- Analyze processes for improvement and scalability, and utilize background and expertise to establish and optimize new processes for eventual incorporation into large scale cGMP high end laboratory medical equipment and Single-Use-Product manufacturing processes
- Perform process capability and gap analysis
- Utilize technology and Lean design methodologies to improve process efficiency
- Improve process control and reduce COGS by utilizing automation
- Provide engineering solutions that maximize process efficiency and improve quality performance of the assigned processes
- Responsible for the maintenance and calibration program per ISO9001, ISO 13485 requirements and ISO 10012 guidelines
- Develop specifications for equipment and process improvement initiatives
- Troubleshoots equipment and processes to resolve issues that may arise during manufacturing
- Maintain accurate and up to date records, including appropriate lab notebook recordings. Capable of achieving deliverables in a timely fashion
- Maintain a working knowledge of calibration fundamentals and hands-on experience in the day-to-day functions of the calibration equipment
- Use existing procedures to perform daily hands-on calibration work, ensuring calibrations are performed as scheduled and as defined by calibration program SOPs.
- Schedule, supervise and review maintenance/calibration activities with outside contractors
- Communicate with outside vendors and/or equipment manufacturers for technical support and to obtain instrument specifications and/or testing procedures for instrumentation
- Perform other duties as assigned.
- Bachelor of Science degree or equivalent in Engineering and 1-3 years’ experience in a cGMP manufacturing facility preferred
- Hands-on experience with scalable manufacturing concepts and methodologies
- Passion for new engineering technologies and innovation
- Experience with manufacturing equipment/automated systems
- Experience with maintenance and calibration systems
- Experience in process improvement plans and process mapping
- Familiarity with cGMPs, ISO9001, ISO13485, ISO10012 and FDA regulatory guidelines
- Computer skills, MS Office, SolidEedge/SolidWorks
- Knowledge in calibration and use of metrology measuring and testing equipment for the purpose of calibrating and adjusting instruments
- Analytical and mathematical skills
- Detail orientation; keen sense for data integrity and accuracy
- Through and clear documentation, communication abilities
- Systematic and organized workflow
- Independent task management and ability to make decisions
- Ability to communicate, both verbally and in writing
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.