- Escritório em Westhoughton
COMPANY MISSION
eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.
POSITION SUMMARY
The Technical Writer – Facilities will be responsible for authoring, reviewing, and maintaining high-quality technical documentation related to facilities engineering, GMP utilities, and infrastructure across all eGenesis sites. This includes supporting commissioning, qualification, and maintenance processes for critical systems such as HVAC, water systems, cleanroom facilities, and compressed gases. The consultant will also contribute to developing and harmonizing standard operating procedures (SOPs), change controls, work instructions, and risk assessments, ensuring inspection readiness. The role requires collaboration with Facilities Engineering, Quality, Validation, and Manufacturing teams to ensure all documentation meets internal standards, cGMP requirements, and regulatory expectations.
PRIMARY 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
BASIC QUALIFICATIONS
- 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
TOTAL REWARDS
- eGenesis is proud to offer competitive compensation including base pay and annual bonus. We take great care in offering our employees excellent benefits including:
- 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
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