Process Technical Writer 5
Core
Creating and maintaining high-quality manufacturing documentation (batch records, GMP docs) to support the production of life-changing therapies.
Role type
Senior Process Technical Writer (Manufacturing/Biotech)
Builds
Accurate, compliant manufacturing process batch records and supporting documentation for life sciences clients.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP documentation authoring, batch record management, cGMP principles, project coordination, cross-functional collaboration, document review management, continuous improvement, Microsoft Office, document management systems
Preferred skills
Scientific discipline background, mentoring technical writers
Technologies
Microsoft Office, Document Management Systems
Responsibilities
Author, review, and update batch records and GMP documentation; Coordinate document timelines for on-time delivery; Partner with cross-functional teams to meet regulatory requirements; Manage document review comments and feedback; Support project meetings and documentation activities; Mentor and support technical writers; Drive continuous improvement initiatives for document quality and compliance.
Seniority
Senior, hands-on IC with mentorship responsibilities
