GMP Technical Writer

This is a remote position.

GMP Technical Writer – Engineering

Location: Indianapolis, IN / Remote Hybrid
Type: Contract
Travel/On-Site: Initial 1 week on-site in Indianapolis, followed by approximately 2–3 on-site days per month. Remaining work may be performed remotely.

Position Overview

Our client, a growing biopharmaceutical manufacturing organization, is seeking an experienced GMP Technical Writer to support the development, revision, and maintenance of GMP documentation. This role will primarily support the Engineering organization (approximately 75%), with additional support across other GMP functions as needed.

Responsibilities

• Write, revise, and update GMP-controlled documentation.
  
• Develop and maintain SOPs, work instructions, protocols, forms, and equipment/engineering documents.
  
• Work with Engineering and other SMEs to translate technical processes into clear, compliant documentation.
  
• Ensure documents align with GMP requirements and site documentation standards.
  
• Support document remediation and updates as site needs evolve.
  
• Approximately 25% of support may extend to other GMP functional groups.
  

Qualifications

• Previous technical writing experience in a GMP-regulated pharmaceutical, biotechnology, or biopharmaceutical environment.
  
• Strong experience developing and revising SOPs, work instructions, protocols, and other controlled documents.
  
• Experience supporting Engineering, Facilities, Maintenance, Calibration, Equipment, or Validation documentation strongly preferred.
  
• Strong understanding of GMP documentation practices and Good Documentation Practices (GDP).
  
• Ability to work independently and collaborate effectively with technical SMEs.
  
• Must be able to travel to Indianapolis for an initial one-week onboarding period and approximately 2–3 days per month thereafter.