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Randstad – Lonza is seeking an Engineer, Engineering - Process (Fixed Term) in Singapore to support biologics manufacturing. As a process SME, you will work across MSAT, Automation, QA, Maintenance, OPEX and Manufacturing to ensure reliable equipment and successful tech transfers.
You will lead investigations, implement improvements, coordinate commissioning and IQ/OQ, and supervise contractors for capital projects, with a strong emphasis on safety and cGMP compliance.
You will be responsible for process engineering activities that support the successful manufacture of biologics products in Lonza Singapore. As subject matter experts, 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.
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 project close out process is completed
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 time
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
An agile career and dynamic working culture
An inclusive and ethical workplace
Lonza is looking to hire a Process Engineer to join our Process Engineering team at our Singapore Tuas facility. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.