Senior Process Engineer, MSAT

LONZA BIOLOGICS TUAS PTE. LTD.; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

A leading company in biotechnology is seeking a skilled professional in technology transfer to support the timely incorporation of manufacturing processes. The ideal candidate will work closely with clients and internal teams, ensuring smooth operations and resolving any process-related challenges. Qualifications include a relevant degree and experience in a technical environment, with strong communication and analytical skills being essential.

Qualifications

• Degree in relevant fields such as Chemical Engineering or Microbiology is required.
• Desirable exposure to biotechnology process development.
• Hands-on technical experience in lab or manufacturing is preferable.

Responsibilities

• Support timely transfer of manufacturing processes into the production facility.
• Write master batch records and develop training packages.
• Provide on-call support during production and resolve process issues.

Skills

Communication

Technical writing

Statistical Data Analysis

Attention to detail

Education

Degree in Chemical Engineering

Degree in Biochemical Engineering

Degree in Biochemistry

Degree in Chemistry

Degree in Microbiology

Tools

Excel

Job description

Key responsibilities:

Technology Transfer

• 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
• Write master batch records and develop operator training packages
• Deliver pre-campaign training and perform post-campaign reviews of assigned processes.
• Support investigations into process issues or deviations, write minor/major deviations are assigned.

Process Support

• 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.

Key requirements:

• Degree in Chemical Engineering, Biochemical Engineering, Biochemistry/ Chemistry/ Microbiology or related discipline.
• Exposure in Biotechnology process development, process support, research or a related manufacturing environment is desirable.
• Prior hands-on technical experience (in a laboratory or manufacturing environment) is desirable.
• 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.
• Demonstrated track record in completing projects under tight timelines.