Associate Technical Writer

Kymanox

Kenosha, Wisconsin, United States

Kenosha, Wisconsin, United States

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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 (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

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 4000 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. To learn more about our company, please visit our website: Life Science Solutions | Kymanox 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.

Kenosha, Wisconsin, United States

Sprachkenntnisse

English

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