FSP-Scientific/Technical Writer Job at Thermo Fisher Scientific, King of Prussia, PA

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  • Thermo Fisher Scientific
  • King of Prussia, PA

Job Description

Thermo Fisher Scientific seeks a scientific/technical writer for sterile manufacturing operations in King of Prussia, Pennsylvania. The role involves developing and maintaining GMP-compliant documentation, ensuring data integrity, and supporting continuous improvement in parenteral product manufacturing.

Responsibilities

  • Prepare and oversee GMP/GLP documents including SOPs, batch records, and laboratory notebooks
  • Support preparation, revision, and archiving of technical documents such as risk assessments and contamination control strategies
  • Generate metrics and KPIs for sterile operations processes and report on compliance status
  • Conduct safety inspections, identify quality improvements, and support GMP self-inspection activities
  • Provide technical support as subject matter expert on GQP topics and data integrity issues

Requirements

  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
  • Minimum 2+ years of experience in relevant technical or manufacturing role
  • Knowledge of cGMP regulations, SOPs, and GLP documentation standards
  • Understanding of aseptic manufacturing principles and sterile operations
  • Proficiency with Word, Outlook, and basic computer navigation
  • Strong written communication and technical documentation skills
  • Preferred: prior GMP manufacturing experience

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