Technical Writer - Facilities

eGenesis; Alabama; On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

90% company-paid medical insurance

Dental and vision insurance

401k with company match

Paid time off and holidays

Job summary

A biotech company in Alabama is looking for a Technical Writer to produce high-quality documentation related to facilities engineering and GMP utilities. The role involves collaboration with cross-functional teams, management of controlled documents, and ensuring compliance with regulatory standards. Candidates should have a BS in a related field and over 5 years of experience in GMP-regulated environments. This position offers competitive compensation and comprehensive benefits.

Qualifications

• 5+ years of experience in GMP-regulated environments.
• Proven success in authoring/reviewing GMP documentation.
• Comfortable presenting to regulatory agencies.

Responsibilities

• Develop and maintain controlled documents for facilities engineering.
• Collaborate with Quality, Validation, and Manufacturing teams.
• Support commissioning, qualification, and maintenance activities.

Skills

Strong knowledge of FDA regulations

Excellent communication skills

Leadership abilities

Cross-functional collaboration

Education

BS in Mechanical, Electrical, Chemical Engineering or related field

Tools

Documentation management systems (e.g., Veeva, Qualio)

Job description

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.