eGenesis · 19 hours ago
Technical Writer - Facilities
Greater Madison Area
Full-time
Onsite
Senior Level
5+ years expeGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering. The Technical Writer – Facilities will be responsible for authoring and maintaining technical documentation related to facilities engineering and GMP utilities, ensuring compliance with regulatory standards and supporting cross-functional teams.
BiopharmaBiotechnologyGeneticsLife ScienceMedical
Responsibilities
Develop and maintain controlled documents including SOPs, work instructions, protocols, and reports for facilities engineering, GMP utilities, and equipment lifecycle management
Author technical assessments, engineering change controls, and risk evaluations for facility systems, ensuring alignment with cGMP, EU Annex 1, ICH, ISPE, and ASTM standards
Support documentation for commissioning, qualification, and maintenance activities for facility and utility systems (HVAC, RO/DI water, cleanroom infrastructure, compressed gases, etc.)
Collaborate cross-functionally with Quality, Validation, and Manufacturing teams to ensure facility documentation supports regulatory inspections, internal audits, and compliance readiness
Partner with Facilities leadership to capture technical content related to capital projects, expansions, and equipment installations into clear, accurate, and inspection-ready documentation
Prepare and maintain standardized templates and document control practices to ensure consistency and alignment with eGenesis quality systems (e.g., Veeva, Qualio)
Provide documentation support for facility deviations, CAPAs, and change controls, including root cause investigations and remediation plans
Assist with training materials and guidance documents for facility operations and quality oversight activities
Ensure all documentation follows phase-appropriate regulatory expectations for both development and GMP-compliant environments
Responsible for speaking to clients and regulatory authorities to explain investigations
Provide strategic oversight for facilities and equipment lifecycle management, control strategies, and inspection readiness
Ensure all facility activities align with cGMPs, engineering best practices, and product quality requirements
Support harmonization of global facility quality standards and training across the eGenesis network
Lead or contribute to investigations related to facility deviations and CAPAs, including root cause and remediation
Partner with Quality & Manufacturing teams to support regulatory submissions, inspections, and closure of observations
Qualification
Required
BS in Mechanical, Electrical, Chemical Engineering or a related field
5+ years of progressive experience in GMP-regulated biotech/pharmaceutical manufacturing environments
Strong knowledge of FDA, EMA, EU Annex 1, ICH Q7/Q9/Q10, ASTM E2500 and engineering best practices
Hands-on experience managing facility systems (e.g., HVAC, BAS, clean utilities, maintenance programs)
Proven success in authoring/reviewing GMP documentation (e.g., change controls, impact assessments, SOPs)
Excellent communication, leadership, and cross-functional collaboration skills
Comfortable presenting to regulatory agencies and senior leadership
Willingness to travel (10–15%) across eGenesis sites as needed
Benefits
Medical insurance (90% company paid)
Dental insurance (90% company paid)
Vision insurance (100% company paid)
401k with a company match
Paid time off and paid sick time
Paid holidays
Company
eGenesis
EGenesis is a gene editing and genome engineering company developing human-compatible engineered organs to treat diseases.
51-200 employees
H1B Sponsorship
eGenesis 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
2025 (4)
2024 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$456MKey Investors
Lux CapitalFresenius Medical Care
2024-09-04Series D· $191M
2021-03-02Series C· $125M
2019-11-07Series B· $100M
Leadership Team
Michael Curtis
President and CEO
Peter Hanson
Chief Operating Officer
Recent News
2026-01-07
2025-12-18
Company data provided by crunchbase