Technical Writer / Validation Documentation Consultant

Location: Tennessee
Duration: 3–6 months

About the Role

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.

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.

Requirements

• 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.

Qualifications

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.