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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, we offer the expertise and resources to help clients deliver innovative gene therapies.

Job Title: Technical Writer II

**Location/Division Specific Information** : US - Massachusetts – Plainville (on-site)

How will you make an impact?

As **RSO,** you’ll play a key role in supporting our GMP manufacturing operations by developing and maintaining high-quality documentation. Your work directly impacts the consistency, safety, and compliance of the treatments we help bring to market.

A day in the Life:

+ Partner with subject matter experts (SMEs) to create and revise GMP-compliant documentation, including SOPs, logbooks, batch records, and technical reports

+ Manage documentation workflows, ensuring content accuracy, version control, and adherence to formatting standards

+ Additional responsibilities may include administrative duties to manage and process-controlled documents for the manufacturing processes

Keys to Success:

Education

+ Associates degree with 3-4 years of experience

+ Bachelor’s degree with 1-2 year of experience

Experience

+ Proven experience conducting interviews or meetings with SMEs to gather technical information

+ Hands-on experience structuring, drafting, and editing GMP-compliant technical documents

+ Demonstrated ability to review and analyze documents for completeness, accuracy, and compliance

Knowledge, Skills, Abilities

+ Excellent written and verbal communication skills; able to translate technical concepts into clear documentation

+ Strong collaboration skills with the ability to engage SMEs and gather information through interviews and meetings

+ Proficient in Microsoft Office and document management systems

+ Detail-oriented with a strong sense of quality and accuracy

+ Able to analyze, structure, and format technical content in a logical, user-friendly way

+ Understanding of GMP principles and ability to assess documents for compliance

+ Willingness to gown aseptically for cleanroom access if needed

Physical Requirements / Work Environment

+ Role is 100% onsite in a GMP manufacturing environment

+ May require periodic cleanroom entry and the ability to gown per sterile manufacturing protocols

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.