Senior Technical Specialist, MM (MFG)

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

Be part of Lonza’s Manufacturing Technical Team (MTT), where you will play a critical role in enabling successful manufacturing operations through technical documentation and operational readiness. As a Senior Technical Specialist, you will develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex technical investigations to ensure manufacturing excellence. This role requires strong technical writing, cross-functional collaboration, and GMP expertise to support safe, compliant, and efficient manufacturing operations.

What you will get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognise high performance.
• Opportunities to collaborate with global cross-functional teams.
• Ongoing learning and professional development opportunities.
• Our full list of global benefits can be found here: Lonza Benefits .

What you will do

• Lead the development, revision, and lifecycle management of Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Change Requests (CRs), risk assessments, and other GMP manufacturing documentation supporting technology transfers and process campaigns.
• Coordinate operational readiness activities by managing documentation, pre-campaign training, equipment and material qualification support, and stakeholder alignment to ensure successful manufacturing execution.
• Lead complex manufacturing investigations, including deviations, trend investigations, root cause analyses, product impact assessments, and CAPA development to support timely product disposition.
• Support manufacturing operations by managing operational activities such as deviation review, CAPAs, change controls, defective material management, audit preparation, and manufacturing technical assessments.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, MSAT, Engineering, and customers to ensure timely completion of technical deliverables and regulatory compliance.
• Drive continuous improvement initiatives by enhancing manufacturing documentation, optimizing operational processes, mentoring junior team members, and promoting data integrity and operational excellence.
• Provide technical expertise during customer interactions, regulatory inspections, and internal audits through effective communication, presentation, and technical documentation support.

What we are looking for

• 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 Master Batch Records (MBRs), SOPs, Change Requests, risk assessments, and other GMP-controlled manufacturing documents.
• Good understanding of manufacturing processes, GMP requirements, deviation investigations, CAPA management, root cause analysis methodologies, and manufacturing quality systems.
• Excellent technical writing, documentation management, communication, and presentation skills with the ability to translate complex manufacturing processes into clear operational instructions.
• Demonstrated ability to lead cross-functional projects, manage competing priorities, influence stakeholders, and mentor junior team members in a dynamic manufacturing environment.
• Strong analytical, problem-solving, and continuous improvement mindset with a commitment to data integrity, compliance, and operational excellence.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourselfAre motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.

Reference: R80271