Process Technical Writer 5

Lonza; Portsmouth (NH); In loco; Confidential; Tempo pieno

Vantaggi offerti da questo lavoro

Agile culture

Inclusive workplace

Performance rewards

Health insurance

Growth opportunities

Cross-functional exposure

Life-changing therapies impact

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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

Conoscenze

Strong written communication

Organizational skills

Interpersonal skills

Formazione

Bachelor's degree or equivalent experience

Strumenti

Microsoft Office

Document management systems

Descrizione del lavoro

Job Title

Process Technical Writer

Location

Portsmouth, NH (On-site)

Shift

1st shift, 8:00AM - 4:30PM, Monday - Friday

About the Role

As a Process Technical Writer, you will play a key role in supporting the production of life-changing therapies by creating and maintaining high-quality manufacturing documentation. Partnering with cross-functional teams across Manufacturing, Quality, and MSAT, you will ensure process batch records and supporting documents are accurate, compliant, and delivered on time to support successful manufacturing operations. This role is ideal for an experienced technical writer who enjoys collaboration, continuous improvement, and driving quality in a regulated environment.

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 for professional growth and development
• Broad exposure to Manufacturing, Quality, and Technical Operations teams
• The opportunity to support the delivery of life-changing therapies

What you will do

• 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

What we are looking for

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

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.