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Technical Writer Level 2

Company: Lonza
Location: Hayward
Posted on: January 26, 2023

Job Description:

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 Accountabilities:

  • 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 within the department
  • Manage global DCFs: Perform initial review for scope, attain sign-offs and justifications, set up review meetings, etc.
  • Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document owners
  • Maintain and review schedules/campaigns: Manage document deadlines while learning more about the manufacturing schedule; begin building a deep understanding of how scheduling works; communicating to group and appropriate departments concerning schedules
  • Comprehend how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document
  • Develop proficiency in editing either upstream or downstream processes
  • Perform other duties as assigned

    Key Requirements:
    • High School Diploma or Equivalent Experience
      • Education: High school diploma or equivalent;
      • Undergraduate degree or equivalent preferred
      • Preferred area of study: Science-related discipline
      • Experience: 3-5 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

        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.

        The full-time base annual salary for this position is expected to range between $57,000.00 and $66,000.00 annually. Compensation for the role will depend on a number of factors, including the location of the successful candidate, qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

        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.

Keywords: Lonza, Hayward , Technical Writer Level 2, Engineering , Hayward, California

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