Technical Writer Level 2
United States, Hayward (California)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 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. 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, 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.
- 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.
- Set realistic goals for technical editing within and outside the department
- Attain sound judgment while drawing on cGMP, interdepartmental, and technical writing knowledge
- Ability to adhere to written instruction
- Maintain attention and concentration to attain compliance within a cGMP atmosphere
- Willingness to defer to others when in need
- Uphold a questioning attitude concerning edits, requests, and daily business-at-large
- 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
- Adept at researching
- Take initiative to identify and address potential problems
- Highly organized
- Very good written and oral communication skills
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.