Senior Process Engineer (MSAT)

LONZA BIOSCIENCE SINGAPORE PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biotech company in Singapore is seeking a Senior Process Engineer to lead the technical transfer of manufacturing processes. This role involves performing technical reviews, managing change controls, and supporting investigations. Candidates should have a degree in a relevant Science field and 7-10 years of experience in biotech or related areas. Join us and contribute to innovative healthcare solutions that improve lives.

Qualifications

• 7-10 years of experience in biotech or development services.
• Understanding and execution of methods like ELISA, potency, PCR, and FACS.
• Experience with change control and CAPAs.

Responsibilities

• Lead transfer of customer processes into the production facility.
• Perform technical reviews of batch records and SOPs.
• Manage change control implementations.

Skills

Technical transfer

Process support

Problem-solving tools

Education

Degree in a relevant Science field

Tools

TrackWise

Job description

Lonza is the pioneer and world leader in the CDMO industry operating across 5 continents, setting the pace with cutting-edge science, smart technology and lean manufacturing. We turn our customers’ break-through innovations into viable therapies and manufacture the medicines of tomorrow.At the heart of every scientific breakthrough are talented individuals collaborating to develop solutions that empower businesses to improve lives. 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. As a Biotechnologist at Lonza Mammalian business, you’ll be part of our globally recognized network, driving the production of mammalian cell culture and treatments.

Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation, and make a difference from day one. Learn new skills and capabilities, and grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

The Senior Process Engineer represents Manufacturing Science and Technology (MSAT) on project teams as technical subject matter expert (SME) and interface with customer technical and quality representatives.

Responsibilities:

Technical transfer

• Lead the timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility.
• Work with other team members, technical experts from Lonza’s customer companies, Manufacturing team, Supply Chain Management team, Quality Assurance (QA) team,
  Quality Control (QC) team, Validation team.
• Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza’s MSAT teams of other sites.
• Design and perform experiments on scale down process in MSAT lab to support process technology transfer.
• Author, review and/ or approves of process-related documents
• Develop and define training programs and requirements to facilitate integration of new manufacturing process into Lonza Bioscience Singapore production facility.
• Interact with customer technical experts as necessary to progress technology transfer.

Process support

• Performs technical review/ approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs.
• Support investigations into process issues/ deviations and if required, coordination of the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab.
• Manage change control implementation for process changes that are driven by process changes/ improvements and coordination of non-GMP and/or non-clinical runs.
• Lead/ support pre-campaign preparation activities.
• Oversight on the production floor to provide support and review of operations.
• Escalate issues to management appropriately and interface with customer on issue resolution.
• Oversight of on-going trainings to ensure alignment between training and process requirements.
• Monitor manufacturing run process data and monitor for run-to-run consistency.
• Identify and drive implementation of process improvements as required.
• Support inspections and audits by customer and regulatory authorities as required.
• Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.

Requirement:

• Degree in a relevant Science field or Equivalent. Relevant 7- 10 years work experience in Lab experience in a biotech or development services, R&D, healthcare and lifescience field
• Bio Assay Area: Understanding and execution of ELISA, potency , PCR and FACS methods.
• Experience in using TrackWise to perform change control, effectiveness check, corrective actions and preventive actions (CAPAs) is highly desirable
• Problem-solving tools such as 5Whys, 5M, fishbone diagrams to identify root causes

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.