PharmEng Technology · 1 day ago
Technical Writer
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
5+ years expPharmEng Technology is a pharmaceutical manufacturing company seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation. This role is critical in ensuring regulatory compliance and supporting quality operations through precise technical documentation.
ConsultingInformation TechnologyPharmaceutical
No H1B
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
Qualification
Required
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
Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment
Applicants must be authorized to work in the United States
Preferred
Experience with TrackWise or other QMS platforms
Company
PharmEng Technology
PharmEng Technology is a pharmaceutical company that provides consultancy services.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Alan Kwong
Managing Director & CEO
Company data provided by crunchbase