Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
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:
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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:
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Education
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High School Diploma/GED with 5-6 years of experience
Associates degree with 3-4 years of experience
Bachelor's degree with 1-2 year of experience
Experience
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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
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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
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Role is 100% onsite in a GMP manufacturing environment
May require periodic cleanroom entry and the ability to gown per sterile manufacturing protocols
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $66,000.00-$98,500.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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