Process Technical Writer Level 2

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.

Building upon an already keen eye for precise and timely editing skills, Technical Writer Level 2 not only accurately and concisely edits cGMP documents while maintaining a busy document schedule but also begins to broaden their responsibilities within the Technical Writing Group, taking a more independent role. Level 2 writers hone their interdepartmental management skills using resources to address comments from internal and external customers as well as regulatory agencies. Stemming from a developing understanding of documentation and manufacturing processes, level 2 writers produce excellence within documents knowing that these documents not only affect the ease of operations within the building but patient safety, drug quality, and business reputation.

Key responsibilities:

  • Edit documents: Review and template documents with accurate, clear, and explicit description and justifications including not only component-related documents (buffers and medias) but either documents concerning early cell development or documents concerning cell quality and purification.

  • Begin to develop proficiency in either upstream or downstream processes.

  • Create new cGMP documents with assistance from within the department.

  • 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 aid of document owners

  • Manage global DCFs: Perform initial review for scope, attain sign-offs and justifications, set up review meetings, etc.

  • Maintain and review schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe; begin building a deep understanding of how scheduling works; communicating to group and appropriate departments concerning schedules

  • Perform other duties as assigned

Key requirements:

  • Undergraduate degree or equivalent preferred

  • Preferred area of study: Science-related discipline

  • 3-5 years Biotech or pharmaceutical manufacturing industry experience;  Document editing

  • Knowledge of cGMP environment/industry as well as scientific language

  • Comprehend how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document

  • Proficient in MS Suite, particularly Word, Excel, and Project

  • Proofreading/editing

  • Experience with document management systems (DMS)/document control practices

  • 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 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.

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. 

Reference: R37457