Senior Process Engineer, MSAT

3 weeks ago

Singapur, Singapore Lonza Full time
Join Our Team as a Senior Process Engineer, MSAT

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and dedication of our people, who work together to devise innovative solutions that help businesses improve people's lives.

We're seeking a Senior Process Engineer, MSAT to join our team in Singapore. As a key member of our manufacturing team, you'll play a critical role in supporting the transfer of customer manufacturing processes into our production facility.

Responsibilities:
  • Support the timely and successful transfer of customer manufacturing processes into our production facility.
  • Work with cross-functional teams to support technology transfer and process development.
  • Perform experiments in our MSAT scale-down process lab to support process technology transfer.
  • 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 disseminate 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.
Requirements:
  • Chemical engineering, biochemical, biochemistry, chemistry, or microbiology degree.
  • Minimum 5 years' experience in biotechnology process development, process support, research, or a related manufacturing environment.
  • 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 and statistical data analysis tools.
  • Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.

We're committed to improving lives all around the world. If you're passionate about making a meaningful difference, we'd love to hear from you.

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