Process Engineer (Fixed Term Contract)

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

You will be responsible for process engineering activities that support the successful manufacture of biologics products in Lonza Singapore. As subject matter experts, you will maintain the interface across all supporting functions (MSAT, Automation, QA, Maintenance, OPEX, EHS) and Manufacturing to ensure seamless manufacturing of product through fit for purpose, reliable equipment design, continuous improvement of process and successful Technical Transfers.

Key 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

About you

Degree in Engineering disciplines or Diploma with Process Engineering experience

Relevant experience in the 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

About us

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees.

An agile career and dynamic working culture

An inclusive and ethical workplace

Compensation programs that recognize high performance

A variety of benefits dependent on role and location