Job Title: Process Technical Writer
Location: Portsmouth, NH (On-site)
Shift: 1st shift, 8:00AM - 4:30PM, Monday - Friday
As a Process Technical Writer, you will play a key role in supporting the production of life-changing therapies by creating and maintaining high-quality manufacturing documentation. Partnering with cross-functional teams across Manufacturing, Quality, and MSAT, you will ensure process batch records and supporting documents are accurate, compliant, and delivered on time to support successful manufacturing operations. This role is ideal for an experienced technical writer who enjoys collaboration, continuous improvement, and driving quality in a regulated environment.
What you will get:- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- Medical, dental, and vision insurance
- Opportunities for professional growth and development
- Broad exposure to Manufacturing, Quality, and Technical Operations teams
- The opportunity to support the delivery of life-changing therapies
What you will do:- 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
What we are looking for:- Bachelor's degree or equivalent experience; scientific discipline preferred
- Minium of 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
