Lead Process Engineer

4 weeks ago


Singapur, Singapore Lonza Full time

Company Overview:

Lonza stands as a prominent force in the life sciences sector, with operations spanning three continents. Our approach to science is straightforward: it is driven by the collective talent of our people, who collaborate to generate innovative ideas that empower businesses to enhance lives. We believe in allowing our employees to take charge of their careers, fostering an environment where their contributions, both significant and minor, can lead to meaningful improvements in the world.

Position Summary:

As a Senior Process Engineer specializing in Upstream Process within the MSAT division, you will be pivotal in facilitating the effective transfer of cell culture or purification stages from customer manufacturing processes into our production facility. Your role will encompass the preparation, execution, monitoring, and follow-up activities related to these processes, as well as leading investigations into any process trends, issues, or deviations.

Key Responsibilities:

  • Conduct thorough investigations into process trends, issues, or deviations, collaborating with multiple departments and customers.
  • Draft change requests and oversee their implementation.
  • Review manufacturing batch records for cell culture or purification processes, providing technical insights to document specialists.
  • Identify training requirements and develop training materials for manufacturing operators, ensuring updates to process batch records for efficient operations.
  • Support plant start-up and pilot/commercial runs, conducting technical investigations and authoring reports to address deviations and troubleshoot process issues.
  • Design and execute small-scale experiments or studies in the laboratory to facilitate technology transfer or investigations, adhering to all safety protocols.
  • Assist in the preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, contributing to customer BLA filings.
  • Maintain process databases and ensure consistency across batch operations.
  • Support inspections and audits conducted by customers and regulatory bodies.
  • Provide technical guidance and share process expertise with MSAT team members and other departments.
  • Perform any additional duties as assigned by your Supervisor/Manager.

Qualifications:

  • A degree or Master's in Biological Sciences, Biochemical Engineering, Chemistry, Microbiology, or a related field.
  • A minimum of 5-10 years of experience in the biotech industry, specifically in cell culture and purification techniques, along with knowledge of Good Manufacturing Practices and regulatory standards.
  • Strong critical thinking abilities for effective problem-solving and decision-making.
  • Exceptional attention to detail and a high level of accuracy in work.

At Lonza, we recognize that our products and services positively impact millions of lives. This responsibility drives us to achieve our business goals ethically and sustainably. Our employees are drawn to the challenges and creativity involved in solving complex problems and developing innovative solutions in life sciences. In return, we offer the fulfillment that comes from making a significant difference in the world.



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