Senior Technical Specialist: GMP Docs & MBR Lead

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Professional development

Competitive compensation

Global cross-functional collaboration

Job summary

Lonza Biologics Tuas Pte Ltd in Tuas, Singapore, is seeking a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex technical investigations to ensure manufacturing excellence.

You will collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers to deliver compliant technical deliverables, drive CAPA processes, and promote data integrity across operations.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or a related scientific discipline.
• Experience in biopharmaceutical manufacturing, manufacturing support, technical operations, process engineering, MSAT, or GMP technical documentation.
• Strong experience authoring and managing Master Batch Records (MBRs), SOPs, Change Requests, risk assessments, and other GMP-controlled manufacturing documents.
• Good understanding of manufacturing processes, GMP requirements, deviation investigations, CAPA management, root cause analysis methodologies, and manufacturing quality systems.
• Excellent technical writing, documentation management, communication, and presentation skills with the ability to translate complex manufacturing processes into clear operational instructions.
• Demonstrated ability to lead cross-functional projects, manage competing priorities, influence stakeholders, and mentor junior team members in a dynamic manufacturing environment.
• Strong analytical, problem-solving, and continuous improvement mindset with a commitment to data integrity, compliance, and operational excellence.

Responsibilities

• Lead the development, revision, and lifecycle management of Master Batch Records (MBRs), SOPs, Change Requests (CRs), risk assessments, and other GMP manufacturing documentation supporting technology transfers and process campaigns.
• Coordinate operational readiness activities by managing documentation, pre-campaign training, equipment and material qualification support, and stakeholder alignment to ensure successful manufacturing execution.
• Lead complex manufacturing investigations, including deviations, trend investigations, root cause analyses, product impact assessments, and CAPA development to support timely product disposition.
• Support manufacturing operations by managing operational activities such as deviation review, CAPAs, change controls, defective material management, audit preparation, and manufacturing technical assessments.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, MSAT, Engineering, and customers to ensure timely completion of technical deliverables and regulatory compliance.
• Drive continuous improvement initiatives by enhancing manufacturing documentation, optimizing operational processes, mentoring junior team members, and promoting data integrity and operational excellence.
• Provide technical expertise during customer interactions, regulatory inspections, and internal audits through effective communication, presentation, and technical documentation support.

Skills

Technical writing

Cross-functional

GMP expertise

Documentation management

Education

Bachelor's degree in Chemical Engineering or related

Tools

Documentation management software

Job description

Lonza Biologics Tuas Pte Ltd in Tuas, Singapore, is seeking a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex technical investigations to ensure manufacturing excellence.

You will collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers to deliver compliant technical deliverables, drive CAPA processes, and promote data integrity across operations.