Technical Writer, Cell
7 days ago
Lonza is a global leader in life sciences, operating across three continents. We're seeking a skilled Technical Writer to join our team in Singapore. As a Technical Writer, you will play a crucial role in developing and revising Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents.
Key Responsibilities:- Develop new MBRs and Work Instructions (WIs) 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 Subject Matter Experts (SMEs)/customers on documentation requirements to ensure specialized topics and comments from internal review are appropriately addressed/discussed.
- 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.
- Closely assigned CAPAs in a timely manner.
- Attend planning and briefing meetings.
- Participate in continuous improvement projects.
- Bachelor Degree in Engineering (Chemical/Biochemical) or Science (Biochemistry/Chemistry/Microbiology) related disciplines preferred.
- Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage.
- Strong technical communication and writing skills.
- Effective interaction skills with MSAT, MFG, QA, customers, and auditors.
- Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint.
- Advanced knowledge in Controlled Document Management System (DMS) Track record in completing projects under tight timelines.
- Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts.
- Ability to influence peers and teams with no direct reporting lines.
- Competencies required: Business Acumen, Customer Focus, Driving Results, Leadership, Collaboration, Agility.
At Lonza, we're committed to improving lives all around the world. We offer a dynamic work environment, opportunities for growth and development, and a chance to make a meaningful difference. If you're passionate about life sciences and technical writing, we encourage you to apply for this exciting opportunity.
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Singapur, Singapore Lonza Full timeJob Title: Technical Writer, CellLonza is a global leader in life sciences, operating across three continents. We're seeking a skilled Technical Writer to join our team in Singapore. As a Technical Writer, you will play a crucial role in developing and revising Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents.Key...
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