Senior Technical Specialist: GMP Docs & Tech Transfers

Lonza; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Global benefits

Professional development

Job summary

Lonza Singapore is seeking a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex investigations to ensure GMP-compliant manufacturing operations. The role emphasizes technical writing, cross-functional collaboration, and data integrity in a fast-paced biopharmaceutical setting.

You will drive lifecycle management of MBRs and SOPs, support readiness activities, and guide CAPA programs while partnering

Qualifications

• Experience authoring GMP-controlled manufacturing documents.
• Strong technical writing and documentation management skills.
• Ability to lead cross-functional projects.

Responsibilities

• Lead the development and lifecycle management of MBRs, SOPs, CRs, risk assessments, and GMP docs.
• Coordinate readiness activities for pre-campaign training and qualification support.
• Lead complex investigations: deviations, CAPA, root cause analyses.
• Support operations: deviation review, change controls, audits.
• Collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers.
• Drive continuous improvement of documentation and processes.
• Provide regulatory documentation support during inspections and audits.

Skills

Technical writing

Cross-functional collaboration

GMP expertise

Documentation management

Root cause analysis

CAPA management

Education

Bachelor's degree in Chemical Engineering

Job description

Lonza Singapore is seeking a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex investigations to ensure GMP-compliant manufacturing operations. The role emphasizes technical writing, cross-functional collaboration, and data integrity in a fast-paced biopharmaceutical setting.

You will drive lifecycle management of MBRs and SOPs, support readiness activities, and guide CAPA programs while partnering