Technical Writer

Flexible & Integrated Technical Services, LLC•Añasco, PR

1d•Onsite

About The Position

This position is for a Technical Writer within the Engineering area, specifically supporting technical services. The role involves working in a GMP-regulated pharmaceutical environment, focusing on documentation and validation activities. The company is a service provider that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services for clients in the Pharmaceutical, Medical Device, and Manufacturing industries. The company prides itself on being flexible, family-oriented, and focused on its resources' well-being.

Requirements

Associate, Bachelor's Degree in Engineering or related field
Previous exposure within the Pharmaceutical or Medical Devices industry
Bilingual, Spanish and English (good communication)
Experience in Controlled documentation and document change systems
Experience in Good Documentation Practices (GDP) and GMP requirements
Ability to draft validation protocols and related documentation
Experience in Collecting measurements and data during experiments
Treats everyone like family, especially resources, clients and team members
Customer service pro
Full of bright ideas and eager to innovate
Brings top-quality results to the table

Responsibilities

Support documentation and validation activities in a GMP regulated pharmaceutical environment
Create, revise, and maintain controlled documents in electronic document management systems
Draft validation protocols, reports, and related supporting documentation
Execute document changes following change control procedures and GDP requirements
Collect measurements and experimental data according to approved protocols and procedures
Ensure data integrity, accuracy, and compliance with Good Documentation Practices
Collaborate with cross functional teams to support quality and validation initiatives
Support audits, inspections, and internal quality reviews as needed.