eGenesis · 10 hours ago
Technical Writer - Manufacturing
Northwest, Indiana
Full-time
Onsite
Senior Level
5+ years expeGenesis is dedicated to giving patients with organ failure a second chance at life through genome engineering. The Technical Writer - Manufacturing will be responsible for authoring and managing technical documentation, conducting investigations, and supporting training for manufacturing personnel in a GMP-regulated environment.
BiopharmaBiotechnologyGeneticsLife ScienceMedical
Responsibilities
Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation
Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams
Provide relevant experience for training manufacturing and technical personnel both directly and indirectly
Establish a scalable framework and organization for execution of technical and quality documentation
Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
Identify cross-functional team members and assemble the investigation/authoring teams
Confirm corrections/containment identified based on the investigation results
Determine the appropriate data sources to be evaluated for the investigation and obtain the required data
Investigate the root cause(s) of the issue and document the investigation results
Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan
Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
Manage multiple investigations at any given time
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 Biology, Mechanical, Electrical, Chemical Engineering or a related field
5+ years of experience in a GMP-regulated biotechnology, cell therapy, gene therapy, or pharmaceutical manufacturing environment
Strong working knowledge of GMP regulations, including FDA, EMA, EU Annex 1, and relevant ICH guidelines
Proven experience authoring and managing GMP documentation, including batch records (MBRs/EBRs), SOPs, work instructions, deviations, investigations, and CAPAs
Demonstrated experience leading or authoring investigations, including root cause analysis, CAPA development, and effectiveness checks
Hands-on experience supporting manufacturing operations and working cross-functionally with Manufacturing, MSAT, Process Development, and Quality teams
Strong ability to translate manufacturing processes and technical information into clear, compliant documentation
Experience supporting regulatory inspections, audit responses, and inspection readiness activities
Strong written communication, organizational, and stakeholder management skills
Ability to manage multiple documentation and investigation projects in a fast-paced, GMP manufacturing environment
Ability to work onsite in Northwest, IN and support cross-site activities as needed
Preferred
Experience with electronic QMS and/or eBR systems (e.g., Veeva, TrackWise, Qualio, etc.) is a plus
Experience in cell therapy, gene therapy, or biologics manufacturing is preferred
Benefits
Medical insurance (80% company paid)
Dental insurance (80% 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