FSP-Scientific/Technical Writer
Thermo Fisher Scientific · King Of Prussia, PA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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