Technical Writer

Join to apply for the

Technical Writer

role at

Kymanox

Location : Indianapolis, IN

Salary : $60,000.00–$85,000.00

Posted : 2 weeks ago

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.

About the Role

Kymanox is seeking an experienced

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 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.

Desired Aptitude And Skill Set

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.

Compensation

Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.

About Kymanox

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4,000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. 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.

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