Kymanox
Join to apply for the
Associate Technical Writer
role at
Kymanox .
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 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.
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 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, 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
Compensation Hourly rate commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.
Seniority Level Entry level
Employment Type Contract
Job Function Marketing, Public Relations, and Writing/Editing
Industries Professional Services
About Kymanox Kymanox is a life sciences professional services company dedicated to life sciences who has successfully delivered over 4 000 projects across 20 + countries. We provide an outstanding opportunity for learning and career advancement in the life science industry. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learning in our service offerings and the life science industry as a whole.
Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start‑up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
Kymanox is an equal‑opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
#J-18808-Ljbffr
Associate Technical Writer
role at
Kymanox .
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 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.
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 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, 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
Compensation Hourly rate commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.
Seniority Level Entry level
Employment Type Contract
Job Function Marketing, Public Relations, and Writing/Editing
Industries Professional Services
About Kymanox Kymanox is a life sciences professional services company dedicated to life sciences who has successfully delivered over 4 000 projects across 20 + countries. We provide an outstanding opportunity for learning and career advancement in the life science industry. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learning in our service offerings and the life science industry as a whole.
Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start‑up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
Kymanox is an equal‑opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
#J-18808-Ljbffr