Process Technical Writer 5

Lonza•Portsmouth, NH

1d•Onsite

About The Position

The Process Technical Writer supports the production of life-changing therapies by creating and maintaining high-quality manufacturing documentation. Working with cross-functional teams across Manufacturing, Quality, and MSAT, the role ensures process batch records and supporting documents are accurate, compliant, and delivered on time to support manufacturing operations. The position is suited to an experienced technical writer who values collaboration, continuous improvement, and quality in a regulated environment.

Requirements

Bachelor's degree or equivalent experience; a scientific discipline is preferred.
At least 5 years of experience in a manufacturing, biotechnology, pharmaceutical, or related environment.
Experience creating, reviewing, or managing GMP documentation and batch records.
Strong understanding of cGMP principles and regulated manufacturing environments.
Ability to manage multiple projects and priorities while meeting critical deadlines.
Strong written communication, organizational, and interpersonal skills.
Experience with Microsoft Office applications and document management systems.

Nice To Haves

A degree in a scientific discipline.

Responsibilities

Author, review, and update batch records and GMP documentation supporting manufacturing operations.
Coordinate document timelines and support on-time delivery of batch records and related documents.
Partner with cross-functional teams to ensure documentation meets regulatory and business requirements.
Manage document review comments and incorporate feedback into final approved documents.
Support project meetings and coordinate documentation activities across multiple customer programs.
Mentor and support technical writers through peer reviews, coaching, and knowledge sharing.
Drive continuous improvement initiatives that enhance document quality, compliance, and operational efficiency.