GMP Process Technical Writer — On-site Manufacturing Docs

Lonza; Portsmouth (NH); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Medical, dental, and vision insurance

Professional growth opportunities

Exposure to Manufacturing, Quality, MS

Opportunities to contribute to life‑im

Job summary

Lonza in Portsmouth, NH is seeking a Process Technical Writer to support manufacturing documentation for life-changing therapies. You will author and update GMP batch records, coordinate timelines, and collaborate with Manufacturing, Quality, MSAT to ensure regulatory compliance and on-time delivery.

The role emphasizes collaboration, continuous improvement, and working in a regulated biotech environment. On-site 1st shift with strong growth opportunities and a comprehensive benefits package.

Qualifications

• Bachelor's degree or equivalent experience; scientific discipline preferred.
• Minimum 5+ years in manufacturing, biotech, pharma, 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 deadlines.
• Strong written communication, organizational, and interpersonal skills.
• Experience with Microsoft Office applications and document management systems.

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.

Skills

GMP documentation

cGMP principles

Project management

Strong written communication

Education

Bachelor's degree

Tools

MS Office

Document management systems

Job description

Lonza in Portsmouth, NH is seeking a Process Technical Writer to support manufacturing documentation for life-changing therapies. You will author and update GMP batch records, coordinate timelines, and collaborate with Manufacturing, Quality, MSAT to ensure regulatory compliance and on-time delivery.

The role emphasizes collaboration, continuous improvement, and working in a regulated biotech environment. On-site 1st shift with strong growth opportunities and a comprehensive benefits package.