Job Description
This role is based only based in Kenosha, on-site is required, and candidate must be located in or near Kenosha.
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 (Contract) 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.
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
Educational Background Bachelor’s degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or related STEM discipline
Experience
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
Desired Aptitude and Skill Set
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
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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 (Contract) 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.
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
Educational Background Bachelor’s degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or related STEM discipline
Experience
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
Desired Aptitude and Skill Set
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
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