Technical Writer

Remote Across India

6 to 12 months + Contract

We are seeking a detail-oriented and experienced Technical Writer with expertise in Good Manufacturing Practices (GMP) and GxP-compliant documentation, specifically for wiring diagrams, schematics, and installation documentation in a regulated manufacturing environment. The ideal candidate will have a strong understanding of regulated environments and the ability to produce high-quality documentation that meets regulatory and internal standards.

Key Responsibilities:

• Create, edit, and maintain wiring diagrams , schematics , installation qualification (IQ) protocols, and system documentation for equipment and facilities in GxP-compliant environments.
• Collaborate with Engineering, Validation, QA, and Manufacturing teams to ensure accurate and complete documentation aligned with FDA 21 CFR Part 11 , EU Annex 11 , and GMP guidelines .
• Develop and revise Standard Operating Procedures (SOPs) , Work Instructions (WIs) , and technical manuals for electrical and instrumentation systems.
• Ensure all documentation meets regulatory, customer, and internal audit requirements.
• Review and update legacy documents to meet current compliance standards.
• Assist in preparing validation documentation, including FAT, SAT, IQ, OQ protocols and reports.
• Maintain document version control in compliance with Document Control systems (e.g., Veeva Vault, MasterControl, or similar).
• Participate in audits and provide documentation support during inspections.

Requirements:

• Bachelor's degree in Engineering, Technical Writing, Life Sciences, or related field.
• 3+ years of experience as a Technical Writer in a regulated GxP environment (pharmaceutical, biotech, or medical device).
• Strong understanding of GMP regulations , GxP principles , and electrical wiring standards .
• Proficiency in creating and interpreting wiring diagrams and technical schematics.
• Experience with AutoCAD , EPLAN , or other engineering drawing tools (a plus).
• Familiarity with validation lifecycle documentation (URS, IQ, OQ, PQ).
• Excellent written and verbal communication skills.
• Strong attention to detail and a commitment to documentation accuracy.
• Experience with document management systems (e.g., Veeva, Documentum, MasterControl).

Preferred Qualifications:

• Knowledge of PLC systems , SCADA , or Client wiring in cleanroom/controlled environments.
• Prior experience in FDA-regulated industry audits and documentation remediation.
• Certification in Technical Writing or GxP compliance.