Audit jobs in Malaysia

We are looking to hire a MSAT Lead Engineer (USP, Tech Transfer) to lead the timely and successful transfer of the cell culture stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Role will lead the preparation, execution, process monitoring and post-campaign activities for cell culture stages of the customer’s manufacturing processes at Lonza Singapore production facility and also lead investigations into process trends, issues or deviations.

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Daily company bus from the MRT location near your home to and from the Tuas site.
• Fully paid medical insurance, and option to enrol family members at partially subsidized premiums.

Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

• Technology Transfer: Lead the timely and successful transfer of the cell culture stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Work with other MSAT team members, technical experts from Lonza’s customer companies or Lonza donor sites, Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.
• Process Support: Lead the preparation, execution, process monitoring and post-campaign activities for cell culture stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with all processes in the facility and develop ability to support/lead activities across multiple processes. Monitor processes on a regular basis to have further understanding of process behavior and prospectively identify process issues. Develop ability to generalize issues across processes.
• Write change requests and drive to implementation as needed.
• Review cell culture process manufacturing batch records and provide technical input to MFG technical document writing specialists.
• Identify training needs and provide training materials for MFG operators on cell culture process batch records. Work with MFG to update process batch records to enable robust manufacturing operations.
• Support plant start-up and pilot/commercial runs and perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for cell culture operations.
• Design and perform/ support small-scale experiments/ studies in lab to support technology transfer or investigations.
• Follow all applicable lab safety policies.
• Support preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.
• Maintain process databases and monitor batch to batch consistency of operations.
• Support inspections and audits by customer and regulatory authorities.
• Provide technical guidance and share process knowledge to MSAT team members and other departments.
• Any other duties as assigned by your Supervisor/Manager.

• Over 5+ years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
• Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/microbiology or related discipline.
• Extensive work experience in Biotechnology process development, process support, research or a related manufacturing environment.
• Prior hands-on experience in cell culture, experimental technique and equipment.
• Knowledge of Excel as well as Statistical Data Analysis tools.
• Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.
• Excellent technical writing skills, ability to provide attention to detail is essential.
• Demonstrated track record in completing projects under tight timelines.
• Experience in mentoring or coaching team members is an advantage.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.