Process Development Engineer 2, MSAT - DSP
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 Singapore? 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.
As a Process Development Engineer you will be responsible for supporting technology transfer of customer’s manufacturing process into Lonza’s Singapore production facility and working closely with customer to identify and resolve technology transfer gaps and process issues. Provide process support to manufacturing as required.
Key responsibilities :
Support the timely and successful transfer of the customer’s manufacturing process into the Lonza Singapore production facility. Work with other team members to support technology transfer.
Perform/support experiments in the MSAT scale-down process lab to support process technology transfer. Follow all applicable lab safety policies.
Provide floor and on-call support for projects being transferred
Work closely with customers to identify and resolve tech transfer gaps and process issues
Review master batch records and develop operator training packages
Deliver pre-campaign training and perform post-campaign reviews of assigned processes
Support/lead pre-campaign preparation activities (BR review, training, change requests) for assigned projects per pre-defined schedule
Provide floor and on-call support during production. Escalate issues to management appropriately and interface with customer on issue resolution
Compile and disseminated daily process updates
Ensure presence on the floor to support production and MSAT review of operations
Support investigations into process issues or deviations, write minor/major deviations.
Support/lead the investigation into process trends to support process monitoring requirements, support preparation of APR and CPV reports, perform work-stages to support customer BLA filing.
Keep current appropriate databases with MFG process data and analyze to monitor run to run consistency for manufacturing operations and identify opportunities for improvement.
Support inspections and audits by customer and regulatory authorities as required.
Any other duties as assigned by your Supervisor/Manager
Chemical engineering/ biochemical/ biochemistry/chemistry/microbiology or related discipline
2 – 4 years experience in Biotechnology process development, process support, research or a related manufacturing environment is desirable
Knowledge of purification and the principles of aseptic processing within a classified environment.
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.
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.
Vaccination status: As the above role requires you to work on-site*, only fully vaccinated** employees will be shortlisted for the role. For fully vaccinated applicants, please indicate your vaccination status as “fully vaccinated” when applying for the role.
*In line with the latest advisory from the Ministry of Manpower, from 1 January 2022 only employees who are fully vaccinated or have recovered from COVID-19 within the past 180 days, can return to the workplace.
** Lonza adopts the definition of “fully vaccinated” by the Ministry of Health in Singapore which means that you:
(a) have received the full regimen of WHO EUL vaccines from a specific manufacturer; and
(b) have met the prescribed post-vaccination period for the respective vaccine to be fully effective.
We provide company transport, both ways, at multiple pick up points.