Kymanox · 3 weeks ago
Associate Technical Writer
Charlottesville, Virginia
Full-time
Onsite
New Grad, Entry Level
0+ years expKymanox is a life sciences professional services company dedicated to delivering high-quality projects across the biotechnology, pharmaceutical, medical device, and combination product industries. They are seeking an Associate Technical Writer to author and revise compliant documentation in a cGMP environment, collaborating with subject matter experts to ensure regulatory compliance.
Life ScienceTechnical Support
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
Qualification
Required
Bachelor's degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or related STEM discipline
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
Preferred
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
Company
Kymanox
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
201-500 employees
H1B Sponsorship
Kymanox has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-08-23Debt Financing
2021-08-02Series Unknown
Leadership Team
Stephen M. Perry
CEO
Nicholas Ciccarelli
Chief Technology Officer
Recent News
EIN Presswire
2025-05-08
GlobeNewswire News Room
2024-11-29
Company data provided by crunchbase