Technical Operations, Technical Writer Ii

Plainville, MA, US, United States

Job Description

Work Schedule




Standard (Mon-Fri)

Environmental Conditions




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:


----------------------

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


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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


--------------

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

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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Job Detail

  • Job Id
    JD6739517
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    66000.0 98500.0 USD
  • Employment Status
    Permanent
  • Job Location
    Plainville, MA, US, United States
  • Education
    Not mentioned