Technical Writer Level 4
Employment Type: Full-Time
United States, Hayward (California)
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.
As an already well-versed technical writer, level IV writers' precise and accurate writing, editing, and planning skills bring about a greater leadership role within the technical writing group and Lonza. These writers become the backbone of the technical writing group, providing support within the department and also throughout the business, offering keen insight to process-related knowledge and manufacturing as related to batch records and instructions. Technical Writer Level IV has a deep understanding of how their work directly affects ease of operations within the building, patient safety, drug quality, and business reputation.
* Edit and create documents: Review and template documents (including buffers, media, upstream and downstream documents) with accurate, clear, and explicit description and justifications while developing proficiency in both upstream and downstream processes.
* Creates new cGMP documents with minimal assistance
* Adhere to established departmental practices and protocols
* Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the minimal aid of document owners
* Maintain and review schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe; continue building a deep understanding of how scheduling works; communicating to group and appropriate departments concerning schedules
* Mentor/coach/train fellow technical writers at or below level 3 while also providing peer reviews and other support, and help with aiding the hiring process of prospective technical writers
* Act as designee for supervisor; may include work on CAPA assignments to drive improvements
* Able to author any low/minor deviations and manage global DCFs
* Undergraduate degree preferred or equivalent experience
* Preferred area of study: Science-related discipline
* Advanced years Biotech or pharmaceutical manufacturing industry experience
* Batch record editing
* Strong knowledge of cGMP environment/industry as well as scientific language
* Advanced level in MS Suite, particularly Word, Excel, and Project
* Advanced Proofreading/editing
* Experience with document management systems (DMS)/document control practices
* High skill level concerning editing/creating tables/various styles using word processing tools
Every day, Lonza's products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievement 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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.