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Stark Pharma Solutions Inc
Technical Writer / Validation Documentation ConsultantStark Pharma Solutions Inc • Nashville, TN, United States
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Technical Writer / Validation Documentation Consultant

Technical Writer / Validation Documentation Consultant

Stark Pharma Solutions Inc • Nashville, TN, United States
14 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Position: Technical Writer / Validation Documentation Consultant
Location: Tennessee
Duration: 3 6 Months

Job Overview

The Technical Writer / Validation Documentation Consultant will support pharmaceutical cGMP packaging operations by developing and maintaining compliant technical and validation documentation for packaging processes, equipment, components, and new product introductions.

Key Responsibilities

  • Develop product-specific Master Batch Records (MBRs), Master Setup Sheets, Work Instructions, and controlled manufacturing documentation.
  • Prepare validation protocols, test scripts, and qualification documentation.
  • Develop and support FAT, SAT, Engineering Studies, IQ, OQ, and PQ documentation.
  • Design equipment- and component-specific validation tests.
  • Support execution of validation and qualification protocols as required.
  • Support label requests, labeling accuracy, traceability, and serialization-related changes.
  • Assist with new product introductions and packaging/component evaluations.
  • Support Change Controls, Deviations, CAPAs, Risk Assessments, and Root Cause Investigations.
  • Collaborate with Engineering, Quality, Operations, Production, Validation, and Technical Services teams.
  • Ensure documentation meets GMP, FDA, customer, and internal requirements.
  • Support continuous improvement and documentation standardization activities.

Required Qualifications

  • Pharmaceutical cGMP experience is required.
  • Hands-on technical writing experience in a pharmaceutical, biotech, or regulated GMP manufacturing environment.
  • Direct experience authoring validation and qualification documentation.
  • Experience with FAT, SAT, Engineering Studies, IQ, OQ, and/or PQ protocols.
  • Experience developing or maintaining Master Batch Records, manufacturing instructions, Master Setup Sheets, Work Instructions, or similar controlled documentation.
  • Understanding of equipment and process validation within pharmaceutical manufacturing or packaging operations.
  • Experience developing equipment- and component-specific validation tests.
  • Experience supporting validation or qualification protocol execution is strongly preferred.
  • Familiarity with packaging equipment, manufacturing processes, or new product introductions.
  • Knowledge of FDA and GMP documentation requirements.
  • Experience with Change Controls, Deviations, CAPAs, Risk Assessments, and Root Cause Investigations is preferred.
  • Strong technical writing, attention to detail, organization, and communication skills.
  • Ability to collaborate with Engineering, Quality, Operations, Production, and Validation stakeholders.
  • Proficiency with Microsoft Word, Excel, Teams, and Office 365.
  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Technical Writing, or a related technical/scientific discipline is preferred. Relevant pharmaceutical cGMP and validation experience may be considered in lieu of a specific degree.
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Technical Writer / Validation Documentation Consultant • Nashville, TN, United States

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