MSAT Process Technical Writer

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

United States, Portsmouth (New Hampshire)

MSAT Process Technical Writer

Location: Portsmouth, NH, USA

Monday-Friday, Onsite

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.

What you will get:

• 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.

What you will do:

• 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 elevate risks that could impact manufacturing readiness.
• Partner with internal subject matter experts to ensure documentation meets regulatory, customer, and business requirements.

What we are looking for:

• 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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.