GMP Technical Lead: MBRs, SOPs & CAPA Expert

Lonza Group Ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Dynamic culture

Inclusive workplace

Compensation programs

Global collaboration

Learning & development

Job summary

Lonza Group Ltd. in Tuas, Singapore, is seeking a rigorous documentation and manufacturing specialist to lead MBR/SOP lifecycle and GMP documentation for technology transfers and campaigns.

You will coordinate readiness activities, support investigations, and collaborate with QA, MSAT, Engineering, and customers to ensure compliant, timely execution. The role emphasizes strong technical writing, cross-functional leadership, and mentorship in a dynamic biopharma environment with opportunities for

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or related field.
• Experience in biopharmaceutical manufacturing, manufacturing support, technical operations, process engineering, MSAT, or GMP documentation.
• Strong experience authoring and managing MBRs, SOPs, Change Requests, risk assessments, and GMP-controlled docs.
• Solid understanding of GMP, deviation investigations, CAPA, root cause analysis, and manufacturing quality systems.
• Excellent technical writing, documentation management, communication, and presentation skills.
• Proven ability to lead cross-functional projects, manage priorities, influence stakeholders, and mentor juniors.
• Analytical, problem-solving, and continuous improvement mindset with data integrity and compliance focus.

Responsibilities

• Lead development, revision, and lifecycle management of MBRs, SOPs, CRs, risk assessments, and GMP docs for transfers and campaigns.
• Coordinate readiness activities: training, qualification support, and stakeholder alignment for manufacturing execution.
• Lead investigations (deviations, trend studies, CAPA, impact assessments) to support product disposition.
• Support operations with deviation review, CAPAs, change controls, material management, and audits.
• Collaborate with Manufacturing, QA, MSAT, Engineering, and customers to meet technical deliverables and compliance.
• Drive continuous improvement by updating docs, optimizing processes, mentoring teammates, and ensuring data integrity.
• Provide technical input during customer interactions, regulatory inspections, and internal audits.

Skills

MBR authoring

SOP authoring

Deviation investigations

CAPA management

Technical writing

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in Chemical Engineering or related field

Tools

GMP Documentation Systems

MSAT tools

Quality Management System (QMS)

Job description

Lonza Group Ltd. in Tuas, Singapore, is seeking a rigorous documentation and manufacturing specialist to lead MBR/SOP lifecycle and GMP documentation for technology transfers and campaigns.

You will coordinate readiness activities, support investigations, and collaborate with QA, MSAT, Engineering, and customers to ensure compliant, timely execution. The role emphasizes strong technical writing, cross-functional leadership, and mentorship in a dynamic biopharma environment with opportunities for