Technical Writer

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.

With an eye for detail, Technical Writers review and edit cGMP documents, allowing these records to not only be timely and accurate but also easily understood by scientists, regulatory agencies, manufacturing workers, et al. Providing an important role in producing quality while proofreading, editing, and reviewing documents,  Level 1 Writers begin to provide support and communication among a multitude of different departments, organize and prioritizes document schedules, and accurately and precisely review batch records used on the manufacturing floor. Level 1 Technical Writers, therefore, help create the foundation for successful product campaigns by producing error-free documentation, knowing that the documents they produce 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—the majority of which are revisions to existing component-related documents, i.e. buffers and medias—with accurate, clear, and explicit description and justifications.  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 and other technical writers 
  • Maintain schedules: Notify associated departments of deadlines and keep documents within their scheduled timeframe 
  • Perform other duties as assigned 

Key requirements:

  • Education: High school diploma or equivalent; 
  • Undergraduate degree or equivalent preferred
  • Preferred area of study: Science-related discipline
  • Experience:   Intermediate years Biotech or pharmaceutical manufacturing industry experience; Document editing
  • Basic knowledge of cGMPs
  • Manufacturing process knowledge
  • Editing skills
  • 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
  • Adept at researching
  • Take initiative to identify and address potential problems
  • Highly organized
  • Very good written and oral communication skills

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: R35227