Senior Process Engineer, MSAT

3 months ago

Singapur, Singapore Lonza Full time

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.

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

Requirements:

Chemical engineering/ biochemical/ biochemistry/chemistry/microbiology
or related discipline

Minimum 5 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.

Time management, planning, prioritization and delegation skills.

Communication skills – regular, clear and concise communication to manufacturing team, customer representatives, customer auditors and regulatory inspectors (both written and oral).

Ability to manage change and communicate it effectively.

Influencing skills, assertiveness and an ability to challenge views and beliefs.

Strong independent work ethic.

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.

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 achieve 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: R61860

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