PharmEng Technology
Technical Writer Job at PharmEng Technology in Indianapolis
PharmEng Technology - Indianapolis, IN, United States, 46262
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Overview
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About The Job: Technical Writer
Our client, a pharmaceutical manufacturing company, is seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation. This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise, timely, and accurate technical documentation.
Key Responsibilities
- Write, edit, and review high-quality technical documents including deviations, change controls, CAPAs, and other GMP-related records.
- Collaborate with cross-functional teams (QA, Manufacturing, Engineering, etc.) to gather accurate and complete information.
- Ensure all documentation complies with FDA, EU, and internal GMP guidelines.
- Translate complex technical information into clear, concise, and well-structured documents.
- Assist in audit readiness by maintaining organized, traceable documentation.
- Support investigations and root cause analyses by drafting clear summaries and conclusions.
Qualifications
- Bachelors degree in Life Sciences, Engineering, or a related field.
- 5+ years of experience in technical writing within the pharmaceutical or biotech industry.
- Strong knowledge of GMP, deviation management, and change control processes.
- Excellent writing, editing, and communication skills.
- Proficient with Microsoft Office Suite; experience with TrackWise or other QMS platforms a plus.
- Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.
Applicants must be authorized to work in the United States. Sponsorship is not available for this position.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Marketing, Public Relations, and Writing/Editing
- Industries: Pharmaceutical Manufacturing