Senior GMP Documentation & Tech Transfer Specialist

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Global cross-functional collaboration

Professional development opportunities

Lonza Benefits

Job summary

Lonza in Tuas, Singapore, seeks a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and campaigns, and lead technical investigations for manufacturing excellence.

The role requires strong technical writing, GMP expertise, and collaboration across Manufacturing, QA, MSAT, and Engineering to ensure compliant and efficient operations.

Qualifications

• Experience authoring and managing MBRs, SOPs, CRs, risk assessments and GMP-controlled documents.
• Strong technical writing and documentation management skills.
• Ability to lead cross-functional projects and mentor junior team members.

Responsibilities

• Lead development and lifecycle management of MBRs, SOPs, CRs and risk assessments.
• Coordinate readiness activities for technology transfers and campaigns.
• Lead investigations: deviations, trend analyses, root cause and CAPA.
• Support operations: deviation review, CAPA, change controls and audits.
• Collaborate with Manufacturing, QA, MSAT, Engineering and customers to ensure deliverables and compliance.
• Drive continuous improvement of documentation and processes; promote data integrity.

Skills

Technical writing

Cross-functional collaboration

GMP compliance

Documentation management

Regulatory knowledge

Root cause analysis

CAPA management

Data integrity

Mentoring

Education

Bachelor's degree in Chemical Engineering / Biochemical Engineering / Biochemistry / Chemistry / Microbiology / Life Sciences

Job description

Lonza in Tuas, Singapore, seeks a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers and campaigns, and lead technical investigations for manufacturing excellence.

The role requires strong technical writing, GMP expertise, and collaboration across Manufacturing, QA, MSAT, and Engineering to ensure compliant and efficient operations.