Technical Writer / Validation Documentation

The Technical Writer / Validation Documentation Consultant will support a pharmaceutical cGMP packaging operation by developing compliant technical and validation documentation for primary and secondary packaging processes, equipment, components, and new product introductions. The consultant will author product-specific Master Batch Records (MBRs), validation protocols and test scripts, Master Setup Sheets, Work Instructions, and related technical documentation. Responsibilities will include developing and supporting FAT, SAT, Engineering Studies, IQ, OQ, and PQ documentation; designing equipment- and component-specific validation tests; and assisting with protocol execution and qualification activities when required. The consultant will work cross-functionally with Engineering, Quality, Operations, Production, and Technical Services to ensure documentation and qualification activities meet GMP, FDA, customer, and internal requirements. The role may also support change controls, deviations, CAPAs, risk assessments, root cause investigations, packaging/component evaluations, and continuous improvement activities.

• Pharmaceutical cGMP experience required.
• Hands-on technical writing experience within a pharmaceutical, biotech, or similarly regulated GMP manufacturing environment.
• Direct experience authoring validation and qualification documentation.
• Experience developing or supporting FAT, SAT, Engineering Studies, IQ, OQ, and/or PQ protocols.
• Experience writing or maintaining Master Batch Records, manufacturing instructions, Master Setup Sheets, Work Instructions, or similar controlled production documentation.
• Understanding of equipment and process validation within pharmaceutical manufacturing or packaging operations.
• Ability to develop equipment- and component-specific validation tests.
• Experience supporting execution of validation or qualification protocols is strongly preferred.
• Label Requests / labeling accuracy and traceability
• Serialization related changes and impact assessments
• Familiarity with packaging equipment, manufacturing equipment, production processes, or new product introductions.
• Working knowledge of FDA and GMP documentation requirements.
• Experience with change controls, deviations, CAPAs, risk assessments, and/or 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.

Education: Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Technical Writing, or a related technical/scientific discipline preferred. Relevant pharmaceutical cGMP and validation experience may be considered in lieu of a specific degree.