Life Sciences MSAT Process Writer (cGMP Docs)

Lonza Group; Portsmouth (NH); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Career development

Collaborative culture

Competitive compensation

Job summary

Lonza is seeking a Process Technical Writer in Portsmouth, NH, onsite, to create and manage manufacturing batch records and cGMP documentation that support production quality and compliance.

You will coordinate revisions, lead documentation reviews, and translate stakeholder feedback into compliant updates, while partnering with internal SMEs to meet regulatory and business requirements. This role requires a biotech or life sciences background and strong writing skills.

Qualifications

• Bachelor's degree in Biotech/Life Sciences or related field preferred.
• Experience in pharmaceutical/biotech regulated manufacturing preferred.
• Technical writing in biotech/pharma with cGMP environment preferred.
• Strong project management and organizational skills.
• Advanced proficiency with Microsoft Word and document management systems.

Responsibilities

• Create, edit, and format process batch records and cGMP documentation.
• Manage document revisions, including scope reviews, approvals, justifications, and reviews.
• Facilitate document review meetings and drive timely resolution of comments.
• Translate stakeholder feedback into compliant documentation updates.
• Maintain documentation schedules that support campaigns and production timelines.
• Communicate document status and elevate risks impacting readiness.
• Partner with SMEs to ensure regulatory, customer and business requirements are met.

Skills

Strong project management

Attention to detail

Cross-functional collaboration

Effective communication

Education

Bachelor's degree in Biotechnology/Life Sciences or related

Tools

Microsoft Word

Document management systems

Job description

Lonza is seeking a Process Technical Writer in Portsmouth, NH, onsite, to create and manage manufacturing batch records and cGMP documentation that support production quality and compliance.

You will coordinate revisions, lead documentation reviews, and translate stakeholder feedback into compliant updates, while partnering with internal SMEs to meet regulatory and business requirements. This role requires a biotech or life sciences background and strong writing skills.