Jobs · Marketing · New Hampshire

MSAT Process Technical Writer

Lonza · Portsmouth, NH · 2 wk ago
MarketingFull-time

About the role

Join Lonza’s Manufacturing Science & Technology (MSAT) team as a Process Technical Writer, where you will play a critical role in supporting the production of life-changing therapies. In this position, you will create, edit, and manage manufacturing batch records and cGMP documentation that directly support manufacturing operations, product quality, regulatory compliance, and patient safety.

Responsibilities

  • Create, edit, and format process batch records and cGMP documentation to ensure accuracy, clarity, and compliance.
  • Manage document revisions, including scope reviews, approvals, justifications, and review coordination.
  • Facilitate document review meetings and drive timely resolution of comments.
  • Translate stakeholder feedback into compliant and effective documentation updates.
  • Maintain documentation schedules that support manufacturing campaigns and production timelines.
  • Communicate document status and escalate risks that could impact manufacturing readiness.
  • Partner with internal subject matter experts to ensure documentation meets regulatory, customer, and business requirements.

Requirements

  • Bachelor’s degree required; Biotechnology, Life Sciences, or a related discipline preferred.
  • Experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry preferred.
  • Technical writing experience within a biotech, pharmaceutical, or cGMP environment preferred.
  • Strong project management and organizational skills.
  • Advanced proficiency with Microsoft Word and document management systems.
  • Strong attention to detail and the ability to manage multiple priorities effectively.
  • Effective communication and collaboration skills across cross-functional teams.

Benefits

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Medical, dental and vision insurance.
  • Opportunities to collaborate with Manufacturing, MSAT, Quality, and Operations teams.
  • Professional development and career growth within a global life sciences organization.
  • The opportunity to contribute to therapies that positively impact patients worldwide.

Schedule

Monday‑Friday, Onsite

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