Biologics Process Engineer – Manufacturing & Tech Transfer

Randstad – Lonza; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Lonza Singapore is seeking a Process Engineer to support biologics manufacturing, interfacing with MSAT, Automation, QA, Maintenance and OPEX to ensure reliable equipment and successful tech transfers.

Requires a degree or diploma in engineering, experience with operation and maintenance of manufacturing equipment in biopharma or petrochemical settings, strong problem-solving and communication, and experience with change control and GMP documents.

Qualifications

• Degree in Engineering disciplines or Diploma with Process Engineering experience.
• Relevant experience in operation and maintenance of manufacturing equipment, preferably in Biopharmaceutical or Petrochemical facilities.
• Good understanding in process equipment design and operation.
• Strong problem solving ability, troubleshooting and analytical skills.
• Strong written and oral communication skills.
• Experienced working with change control, permit to work, drawing management, documentation etc for day-to-day activities.

Responsibilities

• Provide operational and process support for the successful and uninterrupted operation of manufacturing systems used in manufacture of biologics products like bioreactors, purification equipment, media & buffer systems, heat/cooling systems and CIP/SIP equipment
• Develop and implement best practices and play a key role in improving manufacturing success rates, maintaining compliance, providing for a safe work environment and controlling costs of the manufacturing operations
• Provide daily operational support and maintenance for the manufacture of biologics products in a cGMP environment including modifications and changes to processes and equipment, process troubleshooting, root cause analysis and deviation investigation
• Participate and lead, when required, in all investigations (contaminations, observations, deviations, and discrepancies) relating to the audit, manufacturing process and propose CAPA
• Propose and evaluate modifications to equipment, processes and operations to improve safety, increase efficiency and enhance company goals
• Coordinate and manage the commissioning, IQ and OQ phases of the projects and ensure completed projects and documents/drawings are properly handed over to users and Maintenance
• Supervise outside contractors to develop and implement Capital projects and plant modification
• Involve in new customer tech transfer and risk assessment as process SME and develop, plan & execute work necessary to ensure a successful tech transfer
• Perform technical review as a process SME during the revision of GMP controlled documents (e.g. SOPs, batch records, commissioning or qualification protocols)
• Support the team on audit/inspection at all times

Skills

Process engineering

Troubleshooting

Analytical skills

Strong communication

Change control

GMP knowledge

Education

Bachelor's degree in Engineering or Diploma in Process Engineering

Job description

Lonza Singapore is seeking a Process Engineer to support biologics manufacturing, interfacing with MSAT, Automation, QA, Maintenance and OPEX to ensure reliable equipment and successful tech transfers.

Requires a degree or diploma in engineering, experience with operation and maintenance of manufacturing equipment in biopharma or petrochemical settings, strong problem-solving and communication, and experience with change control and GMP documents.