Senior Technical Specialist, MM (MFG)

About the role

Lonza is hiring a Senior Technical Specialist for its Manufacturing Technical Team (MTT) in Tuas, Singapore. You will enable successful manufacturing operations through technical documentation and operational readiness, developing and managing manufacturing documentation, supporting technology transfers and process campaigns, and leading complex technical investigations.

Key responsibilities

• Lead the development, revision and lifecycle management of Master Batch Records (MBRs), SOPs, Change Requests, risk assessments and other GMP manufacturing documentation for technology transfers and process campaigns.
• Coordinate operational readiness: documentation, pre-campaign training, equipment and material qualification support, and stakeholder alignment.
• Lead manufacturing investigations such as deviations, trend investigations, root cause analyses, product impact assessments and CAPA development.
• Support operations through deviation review, CAPAs, change controls, defective material management, audit preparation and manufacturing technical assessments.
• Collaborate with Manufacturing, Quality Assurance, MSAT, Engineering and customers to meet technical deliverables and regulatory compliance.
• Drive continuous improvement, enhance documentation, optimize processes, mentor junior team members and promote data integrity.
• Provide technical expertise during customer interactions, regulatory inspections and internal audits.

Required profile

• 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 MBRs, SOPs, Change Requests and risk assessments.
• Ability to lead cross-functional projects, manage competing priorities, influence stakeholders and mentor others.

Required skills

• Good understanding of manufacturing processes, GMP requirements, deviation investigations, CAPA management, root cause analysis and quality systems.
• Excellent technical writing, documentation management, communication and presentation skills.
• Analytical, problem-solving mindset with a commitment to data integrity and compliance.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to collaborate with global cross-functional teams.
• Ongoing learning and professional development.