(Contract) Technical Writer

Kymanox • Kenosha, WI

2d

About The Position

Kymanox is seeking an experienced (Contract) 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 of five (5) years 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

Nice To Haves

• Direct experience with 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 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

• Career Level: Mid Level