Associate Technical Writer

Kymanox • Kenosha, WI

2d

About The Position

This posting is for a potential future role as we proactively build our talent pipeline. As new opportunities arise, we’ll review applicants and reach out to those whose experience aligns with our hiring needs. Job Description: Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. Kymanox is seeking an Associate Technical Writer with a strong background in FDA-regulated environments (pharmaceutical, biotechnology, medical device, or combination products). The successful candidate will author and revise high-quality, compliant documentation including Standard Operating Procedures (SOPs), work instructions, test methods, protocols, and reports across multiple functional areas in a cGMP environment.

Requirements

• Minimum 0-2 years of experience of technical writing experience in FDA-regulated pharmaceutical, biotechnology, medical device, or combination product environments
• Demonstrated experience authoring FDA-compliant SOPs, protocols, test methods, work instructions, and reports in a cGMP or QSR setting
• Proven ability to interview SMEs, translate complex technical concepts into clear, concise, and compliant documentation
• Excellent client-facing interpersonal skills — professional, courteous, accommodating, high emotional intelligence (EQ), active listening, and a pleasant communication style
• Bachelor’s degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or related STEM discipline

Nice To Haves

• Understanding of DHF remediation, CAPA-driven documentation updates, or site-readiness projects
• Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation, or process validation documentation
• Experience in or familiarity with regulated environments with high-visibility audits (FDA, EMA, notified bodies)
• Proficiency with Veeva Vault, MasterControl, or similar EDMS platforms
• Resourceful
• Detail oriented
• Ability to work effectively with remote team members
• Highly organized
• Self-directing, self-pacing
• Excellent written and oral English communication skills
• Ability to solicit and utilize subject matter expert input
• Pleasant and positive communication style
• Strong customer-service aptitude
• High energy level
• Excellent problem-solving skills
• Seasoned soft skills (i.e., high EQ)
• Team player

Responsibilities

• Author, revise, and format controlled documents (SOPs, work instructions, protocols, test methods, specifications, reports, etc.) in accordance with client templates and FDA/ICH regulatory expectations
• Collaborate daily with client subject-matter experts (SMEs) across Engineering, Manufacturing, Quality Control, Quality Assurance, Facilities, EHS, Warehouse/Supply Chain, and IT to gather technical content
• Support Design History File (DHF) remediation and gap assessments as needed
• Ensure traceability, consistency, and compliance with 21 CFR 210/211, 820, Part 4 (combination products), EU Annex 11, and data integrity requirements
• Manage document review/approval cycles using client electronic document management systems
• Participate in client meetings, present drafts, and incorporate feedback efficiently while maintaining positive, professional relationships

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees