Technical Writer I needs 1-3 years experience in Technical Writing in a GMP or medical device manufacturing environment.

Technical Writer I requires:

• Previous experience in pharmaceutical, medical device, or biotech industries


• In depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.


• Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.


• Previous experience with technical writing.


•  Hands on understanding of LifeCell Manufacturing Practices and procedures.


• Experience using Veeva Vault, TrackWise and SharePoint applications.


• University Degree BA/BS, Bioscience, Business or Education

Technical Writer I duties:

• Work under general supervision to author changes to documentation, including but not limited to operating procedures, work instructions, batch records and forms.

• Create new or revise existing content with a high degree of quality.

• Act as Initiator for change controls (CCs) and execute all steps to ensure timely completion of changes.

• Participate in project team meetings, work collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality and other subject-matter experts to develop document content.

• Assist subject mater experts (SMEs) in create first drafts from process maps, outlines, and direct observation.

• Ensure that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity.