Technical Writer SOPs & GDEs

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 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.

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.