Process Technical Writer (2008233)

Description

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life -science industries. With over 40 locations around the world, Lonza offers products and services that span the product development process -- from research through final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Headquartered in Basel, Switzerland, Lonza is listed on the SWX Swiss Exchange. Additional company information is available at: www.lonza.com

SUMMARY: Create accurate and complete documentation related to multiple GMP manufacturing processes. Work closely with Manufacturing Technical Services and R&D groups to develop basic understanding of the manufacturing process (sufficient to develop batch records, solution documents, and SOPs), utilizing BFD's, PFD's, technical reports, etc. Draft new manufacturing documents (batch records, solution docs., SOPs, etc.) for incoming manufacturing projects Support revision of existing batch records for on-going or repeat manufacturing campaigns Work with manufacturing, MTS, Product Management, and Quality to create full manufacturing document list and schedule Manage document generation/review to meet agreed upon timelines, working closely with Manufacturing, MTS, Product Management, and Quality Ensure that written instructions are clear and in compliance with cGMPs, and internal standards minimizing operator errors and deviations Write end-of-campaign summary reports in collaboration with MTS, QC, and Manufacturing. Write other technical documents as required.~cb~Required Experience

5 years of GMP biopharmaceutical or pharmaceutical manufacturing experience 3 years of dedicated full-time experience with Batch record writing, editing Highly organized; strong attention to detail. - Strong written and oral communication skills including specific demonstrated skills in writing clear, concise documents that meet GMP regulatory requirements. Strong interpersonal skills. Ability to successfully interact with both internal and external customers Excellent word processing skills (at a minimum, MS Word and Excel required). Experience with Documentum a plus.