GMP Technical Writer

About the role

We are seeking a GMP Manufacturing Documentation Specialist to support multiple technical transfer projects for sterile injectable pharmaceutical products. This role entails authoring, revising, coordinating, and driving approval of GMP manufacturing documentation, with a primary focus on Master Batch Records (MBRs) and related controlled manufacturing documents.

Responsibilities

• Author, revise, and coordinate GMP manufacturing documentation.
• Drive approval of Master Batch Records and related controlled documents.
• Collaborate with cross-functional Subject Matter Experts (SMEs) to gather technical information.
• Translate manufacturing processes into compliant documentation.
• Cook up document reviews and reconcile reviewer comments.
• Facilitate review meetings and drive documentation through the approval process until implementation-ready.
• Support documentation throughout the technical transfer lifecycle, including Engineering, Media Simulation, Clinical, and PPQ manufacturing campaigns.
• Convert validated documentation into commercial Master Batch Records before transferring to Manufacturing Operations.
• Proactively identify gaps and missing manufacturing instructions.

Requirements

• Bachelor's degree in a scientific, engineering, or related technical discipline, or equivalent experience.
• Minimum five years of experience in sterile injectable pharmaceutical manufacturing operations.
• Minimum three years of experience authoring or revising GMP Master Batch Records.
• Knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA+ Data Integrity principles.
• Advanced proficiency in Microsoft Word, including complex document formatting and editing.
• Ability to critically review manufacturing documentation and resolve inconsistencies and GMP concerns.
• Strong attention to detail with exceptional proofreading and document quality skills.

Essential Skills

• Technical writing and document control expertise.
• Compliance and data entry skills.
• Quality assurance knowledge.
• Experience with GMP audits.