Biopharma SOPs & GDEs Technical Writer

Pinnaql, Inc.; United States; Remoto; USD 60.000 - 90.000; Tempo integral

Resumo da vaga

Pinnaql, Inc. is seeking a Technical Writer to develop and revise SOPs and Global Documents Engineering (GDE) documentation for a biopharmaceutical manufacturing environment.

You will translate technical requirements into clear documents, ensure GMP alignment, and collaborate with Engineering, Manufacturing, Validation, and Quality to finalize reviews. This role emphasizes accuracy, consistency, and proper document control.

Qualificações

• Bachelor’s degree preferred in engineering, science, or technical writing.
• At least 2 years of technical writing experience in pharmaceutical or biotechnology operations.
• Experience with SOPs, engineering documentation, and GMP requirements.
• Strong English writing, organizational skills, and attention to detail.

Responsabilidades

• Draft, revise, and format SOPs and GDE documentation covering engineering systems, equipment, and manufacturing support processes.
• Translate technical requirements, engineering standards, and SME input into clear, accurate documents.
• Ensure consistency with global engineering requirements, site procedures, and GMP standards.
• Collaborate with Engineering, Manufacturing, Validation, and Quality to resolve comments and complete reviews.
• Manage document revisions and approval workflows through the electronic document management system.

Conhecimentos

SOPs knowledge

Technical writing

GMP familiarity

English writing

Formação

Bachelor's degree in Engineering/Science/Technical Writing

Ferramentas

Electronic Document Management System

Descrição da vaga

Pinnaql, Inc. is seeking a Technical Writer to develop and revise SOPs and Global Documents Engineering (GDE) documentation for a biopharmaceutical manufacturing environment.

You will translate technical requirements into clear documents, ensure GMP alignment, and collaborate with Engineering, Manufacturing, Validation, and Quality to finalize reviews. This role emphasizes accuracy, consistency, and proper document control.