Process Technical Writer 5

US05 Lonza Houston Inc.; Portsmouth (NH); In loco; USD 95.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision insurance

Professional growth opportunities

Exposure to Manufacturing, Quality, &技

Descrizione del lavoro

Lonza Group Ltd. is seeking a Process Technical Writer in Portsmouth, NH (On-site) to create and maintain GMP documentation and batch records.

You will partner with Manufacturing, Quality, and MSAT to ensure accuracy, compliance, and timely delivery of critical manufacturing documents in a regulated environment. Ideal candidates have a Bachelor’s degree or equivalent, 5+ years in biotech/pharma settings, and strong written communication with proficiency in MS Office and document management

Competenze

• Bachelor's degree or equivalent in a scientific discipline or related field.
• 5+ years of experience in manufacturing, biotech, pharma, or related environment.
• Experience creating/reviewing/managing GMP documentation and batch records.
• Strong understanding of cGMP principles and regulated manufacturing environments.
• Ability to manage multiple projects and meet deadlines.

Mansioni

• Author, review, and update batch records and GMP documentation supporting manufacturing operations.
• Coordinate document timelines and ensure 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 client programs.
• Mentor and support technical writers through peer reviews and knowledge sharing.
• Drive continuous improvement initiatives to enhance document quality, compliance, and operational efficiency.

Conoscenze

Technical writing

Cross-functional collaboration

Attention to detail

Regulatory understanding

Formazione

Bachelor's degree or equivalent

Strumenti

MS 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

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.

Why Lonza

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year.

Lonza is a place where people can make a unique impact, grow their careers and belong.

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.

Join us. Be you.