MSAT Process Technical Writer (Creative Design)
Today, Lonza is a global leader in life sciences operating across five 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.
Lonza in Portsmouth, NH is looking for a MSAT Process Technical Writer. This position is responsible for consistently delivering accurate and high-quality process Batch Records to Manufacturing in a timely manner for a number of different customer projects. With a keen eye for precise and timely editing skills, Technical Writers accurately edit cGMP documents and maintain a busy documentation schedule. Writers hone their interdepartmental management skills using available 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.
Key responsibilities:
Edit documents: Review and template documents with accurate, clear, and explicit description and justifications.
Manage document revision: Perform initial review for scope, attain review and approvals with justifications, set up review meetings, etc.
Manage document comments: Facilitate reviews to 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 timelines to support the manufacturing schedule; communicate and escalate appropriately to maintain document timelines.
Coordinate delivery and timelines for batch records, SOPs and other support documents and participate in customer and Project Team Meetings to align groups in regard to the writing, review, and approval of process of batch records. Effectively work with all Lonza departments to provide technical support, expertise and leadership.
Key requirements:
Bachelor's Degree required, Life Sciences area is preferred.
Working experience of pharma/biotech (or equivalent) preferred.
Technical writing in the biotech industry preferred.
Project management skills required.
Strong MS Word experience required.
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.
