GMP Process Technical Writer - Life Sciences (On-site)

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance rewards

Health insurance

Growth opportunities

Cross-functional exposure

Life-changing therapies impact

Job summary

Lonza is seeking a Process Technical Writer to support manufacturing documentation for life-changing therapies at our Portsmouth, NH site. You will craft and maintain batch records and GMP documents, collaborating with Manufacturing, Quality, and MSAT to ensure timely, compliant deliverables used in production.

The ideal candidate brings 5+ years in regulated environments, strong cGMP knowledge, and excellent writing and organizational skills to drive quality and continuous improvement across

Qualifications

• Bachelor's degree or equivalent experience; scientific discipline preferred.
• Minimum 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.

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

Strong written communication

Organizational skills

Interpersonal skills

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office

Document management systems

Job description

Lonza is seeking a Process Technical Writer to support manufacturing documentation for life-changing therapies at our Portsmouth, NH site. You will craft and maintain batch records and GMP documents, collaborating with Manufacturing, Quality, and MSAT to ensure timely, compliant deliverables used in production.

The ideal candidate brings 5+ years in regulated environments, strong cGMP knowledge, and excellent writing and organizational skills to drive quality and continuous improvement across