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 are currently looking for a Technical Writer to join us in Slough, UK. The primary purpose of this role is to generate and revise documentation for GMP manufacturing ensuring technical accuracy and GMP compliance. The role will be a recognized expert able to provide detailed technical support via multi-functional teams to deliver complex process documentation in collaboration with internal cross functional team members. This role will act as a trainer, coach and mentor to other team members.
Accountable for ownership, oversight and active management of technical documentation templates
Independently manage the creation of new documents and revision of existing GMP documents for highly complex technical changes according to documented procedure to maintain accuracy and compliance with other procedures.
Accountable and responsible for the production and processing of complex batch documentation according to standard timelines, coordinate and control the review, approval and issuance of documentation ensuring availability for use in Manufacturing per production schedule
Actively monitor progress of document creation, routinely communicate and liaise with both internal and external customer teams to ensure potential issues are resolved in a timely manner and all changes are incorporated appropriately and all requirements met
Use and maintenance of the Documentation Management System (DMS) according to documented procedure.
Technically accountable for MSAT during active participation and leading of multi-functional project teams. Accountable for the timely management of required documentation supporting strategic projects and / or revenue generating reports.
Creation and ownership of change controls and completion of change assessments aligned with project goals.
Manage and own the continual improvement of technical templates and related documentation as well as actively promoting and encouraging a culture of change.
Will develop a high level of process understanding and internal customer needs through working with SMEs and disseminates knowledge to the team to develop junior members
Will be a recognized technical expert advising on document style and content, use of DMS, documentation procedures and documentation best practice.
Supervises training of new staff and provides assistance, support and training to others during routine document revision. Provides feedback to team members day-to-day
Editorial and selected technical ownership of content for document groups such as Reports, Process Descriptions, Specifications, CoAs and Process Batch Records.
BSc/BEng in Biological science or biochemical engineering disciplines or equivalent in field experience
Strong operational and process knowledge and adherence to cGMPs
Able to independently own and manage complex and highly technical changes throughout the document change lifecycle from concept to effective state
In depth knowledge and awareness of scheduling requirements and deliverables and understanding of the impact to on time delivery of schedule changes
Good interpersonal and organizational skills with ability to contribute at a high level within a cross functional team
Proven logic and decision making abilities. Makes real time decisions based on knowledge and defined SOPs and policies. Reviews more complex decisions with supervisor and support departments. Provide updates to management on scheduling or process issues based on experience
Proven problem solver and multi task individual with track record of quality decision making and implementing improvements. High levels of attention to technical detail and communication skills both written and verbal as well as interpersonal qualities, self-motivated and positive with a desire to develop own and teams technical knowledge and capability
Actively promotes a continuous improvement and safety culture, Identifying and remediating potential unsafe behaviour in documents and the workplace and implementing ideas that will improve the business area
Effectively multi-tasking on multiple projects and ensures that documents stay on schedule. Presents facts clearly and logically. Clear, concise and accurate presentation. Checks for understanding of different perspectives
Ability to work with project teams to coordinate internal customer review and approval (where applicable)
Good understanding of business impact and responsibilities regarding own role
Consistently deliver whilst monitoring KPI.
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.