Senior GMP Documentation & Tech Transfer Specialist

LONZA BIOLOGICS TUAS PTE. LTD.; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Agile career culture

Inclusive and ethical workplace

Professional development opportunities

Global cross-functional collaboration

Job summary

Lonza in Tuas, Singapore, seeks a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers, and lead complex investigations to uphold GMP standards. You will collaborate with cross-functional teams to ensure timely, compliant deliverables and drive continuous improvement in manufacturing documentation.

You will coordinate readiness activities, contribute to CAPAs and change controls, and provide technical expertise during audits and inspections.

Qualifications

• Strong technical writing skills and GMP documentation experience.
• Experience authoring and managing GMP-controlled docs like MBRs, SOPs, CRs, risk assessments.

Responsibilities

• Lead development, revision, and lifecycle management of MBRs, SOPs, CRs, and risk assessments.
• Coordinate operational readiness activities: training, qualification support, stakeholder alignment.
• Lead complex investigations: deviations, trend analyses, root cause analysis, CAPA development.
• Support manufacturing operations: deviations review, CAPAs, change controls, audit prep.
• Collaborate with Manufacturing, QA, MSAT, Engineering and customers to meet regulatory requirements.
• Drive continuous improvement by improving docs and processes and mentoring teammates.

Skills

Technical writing

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or related field

Job description

Lonza in Tuas, Singapore, seeks a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers, and lead complex investigations to uphold GMP standards. You will collaborate with cross-functional teams to ensure timely, compliant deliverables and drive continuous improvement in manufacturing documentation.

You will coordinate readiness activities, contribute to CAPAs and change controls, and provide technical expertise during audits and inspections.