Technical Writer, SOPs, GDEs

Job not on LinkedIn

🕒 October 21

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔏 Technical Writer

🚫👨‍🎓 No degree required

Where this job comes from

Posted on Pinnaql's careers page, not through a job board

First seen by Remote Rocketship October 21

Logo of Pinnaql

Pinnaql

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Pinnaql is a life‑sciences technical and compliance services firm. It partners with pharmaceutical, biotechnology, radiopharma, cell & gene therapy (CGT), medical device companies, CDMOs and compounding pharmacies to deliver quality systems, lab and manufacturing technical operations, validation (CQV/CSV), automation and digital transformation, and engineering/project management support. Core services include QMS development and eQMS, regulatory and audit support, SOP/CAPA/deviation management, computer system validation and 21 CFR Part 11 compliance, LIMS and data integrity support, equipment and analytical method validation, commissioning/qualification/validation, process and cleaning validation, and automation/robotics integration. Pinnaql's experts embed with client teams to improve compliance, accelerate timelines, optimize manufacturing readiness and support tech transfer from development to commercialization. Offices are listed in Malvern, PA and Indianapolis, IN.

📋 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

🎯 Requirements

• 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 skills • Organizational skills and attention to detail

🏖️ Benefits

• Equal opportunity employer • Supportive, purpose-driven team environment • Opportunity to make a meaningful difference in healthcare and technology

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