Facilities Technical Writer — GMP Systems & Documentation

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

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.