Senior Technical Writer, MFG (CGT)
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Responsibilities
- Develop new MBRs and Work instruction (WI), using existing templates, in support of Technology Transfers and revise existing ones ensuring adherence to approved template/ structure
- Produce high-quality documentation that meets applicable standards/ requirements of the users
- Write and edit technical information/ instructions in a manner to ensure content is factual and accurate.
- Collaborate closely with relevant SMEs/ customers on documentation requirements to ensure specialized topics and comments from internal review are appropriately addressed/ discussed 3. Generate Aseptic Process Simulation Summary Report
- Manage the lifecycle of MBRs including, but not limited to creation, review, revision and approval on product campaign basis
- Maintain a system for tracking changes to be implemented in all upcoming product campaigns
- Communicate actively to address customers' comments and to clarify customers' queries with respect to MBRs
- Deliver MBRs/ WIs with strict adherence to the production schedule
- Support change request process:
- Provide assessments and insights to Change Requests as needed
- Define Change Tasks as needed and close tasks in a timely manner
- Close assigned CAPAs in a timely manner
Requirements
- Open to fresh graduate in sciences with strong technical communication and writing skills
- Effective interaction skills with cross functional teams and customers
- Knowledge in Controlled Document Management System (DMS) and Trackwise or similar systems will be an added advantage
- Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts
- Ability to influence peers and teams with no direct reporting lines
- About Lonza
- Ready to shape the future of life sciences?
Benefits
Additional Information
Lonza is hiring for a Technical Writer role based at our manufacturing site at Tuas, Singapore. The Technical Writer is responsible in the development and/ or revision of Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents e.g. Standard Operating Procedures (SOPs), Work Instructions (WIs) used in the execution of manufacturing processes and/ or onsite operations. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you'll get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Daily company bus from the MRT location near your home to and from the Tuas site. Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.
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