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Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We have an opportunity for a Senior Technical Editor to join our team, working on a hybrid home / office arrangement as the business requires. This role is a FTC covering maternity leave.
The role of the Senior Technical Editor is to manage the creation of new documents and revise GMP documents for complex technical changes.
Key responsibilities:
- Independently manage the creation of new documents and revise GMP documents for complex technical changes according to documented procedure, to maintain accuracy and compliance with other procedures
- Use and maintenance of the Documentation Management System (DMS) according to documented procedure
- Responsible for the production and processing of batch documentation according to standard timelines, coordinate review, approval and issuance ensuring availability for use in Manufacturing per production schedule.
- Monitor progress of document creation and communicate with relevant parties where appropriate in order to resolve potential issues in a timely manner
- Responsible for the timely management and closure of required documentation quality records e.g. DCFs, Tasks and CAPAs
- Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors
- Maintenance of GMP document templates and document style and format standards
- Advise on document style and content, use of DMS, documentation procedures and documentation best practice and provide assistance, support and training to others during routine document revision
What we are looking for:
- Ideally previous experience of editing and workflow management of tasks in DMS for batch records, process descriptions and product specifications mainly in Microsoft Word & Excel
- Able to independently write batch documentation to support new product campaigns. Identifies, understands and communicates potential impact of changes to other functions in a timely manner
- Able to manage changes throughout the document / change lifecycle from document submission to effective state with minimal errors
- Good knowledge of Manufacturing operations to allow independent drafting of documents
- In-depth knowledge and awareness of the Manufacturing schedule and understanding of the impact to on time delivery of schedule changes
- Good interpersonal and organizational skills with ability to work within a cross functional team.
- Able to identify and act with own initiative on situations which require escalation, can recognize an abnormal or potentially impacting event and will routinely escalate to appropriate levels of attention
- Proactively offer suggestions to supervisor, manufacturing or technical owners on process improvements or scheduling issues
- Has excellent attention to detail, interpersonal qualities, self-motivated and positive with a desire to develop technically in their area of expertise and a positive approach to team work
- Trackwise experience highly desired
- Previous experience working in a manufacturing / biotechnology or related industry
- Degree / Higher Education in a scientific related study
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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