Technical Writer SOPs & GDEs

Pinnaql, Inc.; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

SOPs knowledge

Technical writing

GMP familiarity

English writing

Education

Bachelor's degree in Engineering/Science/Technical Writing

Tools

Electronic Document Management System

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

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

Technical Writer SOPs & GDEs

Description

• 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.

Qualifications

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

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.