FSP-Scientific/Technical Writer

Thermo Fisher Scientific

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

Apply

Vacancy posted 9 days ago

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