Technical Writer

Job Code:

Q1073

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JOB DESCRIPTION

The Technical Writer- Technology Transfer will work in collaboration with Quality, Process Development, and Manufacturing to author and revise technology transfer reports, batch records, bills of materials, process descriptions, and engineering specifications. This position will own the technical document lifecycle, working closely with internal and external stakeholders, to ultimately push each document to the approved and effective state.

RESPONSIBILITIES

  • Author and revise GMP documents including technology transfer reports, batch records, bills of materials, process descriptions, and engineering specifications

  • Own documents from drafting through internal and external review,

  • Follow up with reviewers and approval to push documents to the effective state

  • Develop and maintain standardized templates and modules for technical documents

QUALIFICATIONS

  • Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 1 years’ experience in a manufacturing environment.

  • Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 2 years’ experience in a manufacturing environment.

  • Associate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 3 years’ experience in a manufacturing environment.

  • Excellent grammar and writing skills

  • Proficient computer skills

  • Advanced/expert knowledge of Microsoft Word

  • Preferred Qualifications:

  • Experience in Technical writing in a biotechnology or pharmaceutical development and manufacturing environment of medium to high complexity.

  • Experience in a cGMP facility.