GMP Process Technical Writer – On-Site

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Professional growth opportunities

Exposure to Manufacturing, Quality, &技

Job summary

Lonza Group Ltd. is seeking a Process Technical Writer in Portsmouth, NH (On-site) to create and maintain GMP documentation and batch records.

You will partner with Manufacturing, Quality, and MSAT to ensure accuracy, compliance, and timely delivery of critical manufacturing documents in a regulated environment. Ideal candidates have a Bachelor’s degree or equivalent, 5+ years in biotech/pharma settings, and strong written communication with proficiency in MS Office and document management

Qualifications

• Bachelor's degree or equivalent in a scientific discipline or related field.
• 5+ years of experience in manufacturing, biotech, pharma, or related environment.
• Experience creating/reviewing/managing GMP documentation and batch records.
• Strong understanding of cGMP principles and regulated manufacturing environments.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Author, review, and update batch records and GMP documentation supporting manufacturing operations.
• Coordinate document timelines and ensure 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 client programs.
• Mentor and support technical writers through peer reviews and knowledge sharing.
• Drive continuous improvement initiatives to enhance document quality, compliance, and operational efficiency.

Skills

Technical writing

Cross-functional collaboration

Attention to detail

Regulatory understanding

Education

Bachelor's degree or equivalent

Tools

MS Office

Document management systems

Job description

Lonza Group Ltd. is seeking a Process Technical Writer in Portsmouth, NH (On-site) to create and maintain GMP documentation and batch records.

You will partner with Manufacturing, Quality, and MSAT to ensure accuracy, compliance, and timely delivery of critical manufacturing documents in a regulated environment. Ideal candidates have a Bachelor’s degree or equivalent, 5+ years in biotech/pharma settings, and strong written communication with proficiency in MS Office and document management