MSAT Process Documentation Lead (Onsite)

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Professional development

Job summary

Lonza Group Ltd. in Portsmouth, NH is seeking a Process Technical Writer to create, edit, and manage manufacturing batch records and cGMP documentation that directly support manufacturing operations, product quality, regulatory compliance, and patient safety.

The role requires a Bachelor's degree in Biotechnology/Life Sciences, experience in regulated manufacturing, and strong technical writing skills. This is an onsite, Monday–Friday position within Lonza's MSAT team, offering collaboration

Qualifications

• Bachelor's degree in Biotechnology, Life Sciences or related field.
• Experience in pharmaceutical/biotech manufacturing is preferred.
• Technical writing experience in cGMP environments preferred.

Responsibilities

• Create, edit, and format process batch records and cGMP documentation.
• Manage document revisions, approvals, and justifications.
• Facilitate document review meetings and coordinate timelines.
• Incorporate stakeholder feedback into compliant documentation updates.
• Maintain documentation schedules supporting campaigns and production timelines.
• Escalate risks impacting manufacturing readiness.
• Collaborate with internal SMEs to meet regulatory, customer, and business requirements.

Skills

Technical writing

Project management

Attention to detail

Communication

Cross-functional collaboration

Education

Bachelor's degree in Biotechnology/Life Sciences

Tools

Microsoft Word

Document management systems

Job description

Lonza Group Ltd. in Portsmouth, NH is seeking a Process Technical Writer to create, edit, and manage manufacturing batch records and cGMP documentation that directly support manufacturing operations, product quality, regulatory compliance, and patient safety.

The role requires a Bachelor's degree in Biotechnology/Life Sciences, experience in regulated manufacturing, and strong technical writing skills. This is an onsite, Monday–Friday position within Lonza's MSAT team, offering collaboration