Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob 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 reportsManage documentation workflows, ensuring content accuracy, version control, and adherence to formatting standardsAdditional responsibilities may include administrative duties to manage and process-controlled documents for the manufacturing processesKeys to Success:EducationAssociates degree with 3-4 years of experienceBachelor’s degree with 1-2 year of experienceExperienceProven experience conducting interviews or meetings with SMEs to gather technical informationHands-on experience structuring, drafting, and editing GMP-compliant technical documentsDemonstrated ability to review and analyze documents for completeness, accuracy, and complianceKnowledge, Skills, AbilitiesExcellent written and verbal communication skills; able to translate technical concepts into clear documentationStrong collaboration skills with the ability to engage SMEs and gather information through interviews and meetingsProficient in Microsoft Office and document management systemsDetail-oriented with a strong sense of quality and accuracyAble to analyze, structure, and format technical content in a logical, user-friendly wayUnderstanding of GMP principles and ability to assess documents for complianceWillingness to gown aseptically for cleanroom access if neededPhysical Requirements / Work Environment Role is 100% onsite in a GMP manufacturing environmentMay require periodic cleanroom entry and the ability to gown per sterile manufacturing protocols