Biopharma SOPs & GDEs Technical Writer

Validation & Engineering Group, Inc.; United States; On-site; USD 65,000 - 100,000; Full time

Job summary

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

The role requires drafting, revising, and formatting technical documents, translating complex requirements into clear content, and ensuring alignment with GMP standards. Collaboration with Engineering, Manufacturing, Validation, and Quality is essential.

Qualifications

• Bachelor’s degree is preferred.
• 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.

Responsibilities

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

Skills

Technical writing

Document control

English writing

Education

Bachelor’s degree in Engineering, Science, Technical Writing, or related field

Job description

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

The role requires drafting, revising, and formatting technical documents, translating complex requirements into clear content, and ensuring alignment with GMP standards. Collaboration with Engineering, Manufacturing, Validation, and Quality is essential.