PharmEng Technology is hiring: Technical Writer in IndianapolisMediabistro • Indianapolis, IN, United States
PharmEng Technology is hiring : Technical Writer in Indianapolis
Mediabistro • Indianapolis, IN, United States
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job_description.job_card.job_descriptionBachelors 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.
About the job Technical Writer
Technical Writer Deviations & Change Control
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
Applicants must be authorized to work in the United States. Sponsorship is not available for this position.
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Technical Writer • Indianapolis, IN, United States
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