Technical Writer

• Create, update, and prepare controlled documentation such as SOPs, work instructions, protocols, test methods, specifications, and technical reports in alignment with established templates and applicable FDA/ICH regulatory standards
• Work closely with subject-matter experts across Engineering, Manufacturing, Quality, Facilities, EHS, Supply Chain/Warehouse, and IT to collect, clarify, and validate technical information
• Contribute to Design History File (DHF) remediation activities and documentation gap analyses when required
• Maintain document accuracy, traceability, and regulatory compliance with applicable regulations including 21 CFR Parts 210/211, 820, Part 4 (combination products), EU Annex 11, and data integrity expectations
• Coordinate document routing, review, and approval workflows within electronic document management systems
• Attend cross-functional meetings, present draft documents, and integrate feedback efficiently while fostering productive and professional working relationships

Education

Bachelor’s degree in Engineering (Biomedical, Mechanical, or Chemical preferred), Life Sciences, Technical Communication, or a related STEM field

Experience

• At least five (5) years of hands-on technical writing experience within FDA-regulated pharmaceutical, biotech, medical device, or combination product environments
• Strong background authoring compliant SOPs, protocols, test methods, work instructions, and technical reports in cGMP and/or QSR settings
• Demonstrated ability to extract information from SMEs and convert complex technical material into clear, concise, and compliant documentation
• Excellent client-facing communication skills, with a professional demeanor, strong emotional intelligence, active listening abilities, and a collaborative approach