- Supervise daily routine and repair work orders as assigned to enable smooth handover and minimize disruption to production schedule.
- Ensure all routine calibration/ maintenance works are duly carried out as scheduled and in compliance with Engineering standards and procedures.
- Respond on-call for calibration/ service breakdown and support ongoing operations.
- Perform review on GMP instrument alert/alarms that are critical to the production system and activate calibration Associate Engineer to attend to these alerts.
- Perform instrument/ equipment related breakdown/ failure troubleshooting/ recovery with calibration Associate Engineer.
- Supervise vendors/service providers activities for daily routine equipment/ instrument maintenance/ calibration work to ensure equipment/ instrument is maintained in full operational status.
- Perform reviewing of executed calibration/ maintenance work order in CMX and SAP to ensure all GMP documentation related to calibration/ maintenance activities is completed accurately and processed to full completion.
- Communicate to Manager when encounter non-compliance issues including work delay, breakdown, missing parts etc.
- Maintain all site equipment/ instrument in optimum condition in compliance with Good Manufacturing Practice (GMP) & EHS requirements.
- Conduct basic instrument technical training (e.g. Emerson Asset Management System) and educate technical/ Quality requirement in term of GMP/GDP and Data Integrity topics to calibration Associate Engineer.
- Perform instrument calibration Out of Tolerance or deviation investigation, perform Root Cause Analysis for instrument/ equipment breakdowns, addressing any technical instruments enquiries and closing Change Control Tasks.
- Perform instrument related technical enquiries, obsolescence and recommend new instruments based on user requirement etc.
- Prepare/ review Calibration procedures to ensure alignment with existing methods; recommend changes in term of GMP requirement or instrument technical adequacy.
- Review existing instrument range/calibration tolerance to ensure they can meet process requirements for new tech transfer.
- Perform scoping on calibration needs ranging from addition instruments; calibration standard, calibration points and resources requirement.
- Carry out any other duties and responsibilities as assigned by Supervisor/Manager, including but not limited to the above.
- Degree/Diploma in Engineering or Equivalent.
- Understands cGMP, GDP & GEP principles and requirements.
- Experience in calibration of manufacturing equipment/ instrument, preferably in the Biopharma industry.
- Good understanding in process instrument design and operation.
- Strong problem solving ability, troubleshooting and analytical skills.
- Strong written and oral communication skills.
- Excellent Planning and work management skills.
- A team player, with the ability to work across functional teams.
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Lead Engineer, Engineering - Singapur, Singapore - Lonza
Description
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.
Did you know that we are the 1st biologics contract manufacturer in ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The Lead Engineer is responsible to supervise daily routine and repair work orders as assigned. Role will troubleshoot equipment/ instrument breakdowns and carry out basic repairs. Supervise vendors/service providers activities for routine equipment/ instrument maintenance/ calibration work to ensure equipment/ instrument is maintained in full operational status. The role will also supervise and train Associate Engineer on production system to improve their knowledge and capability. And perform Root Cause Analysis for equipment/ instrument breakdowns.
Key responsibilities:
Key requirements:
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.
Reference: R56674
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