Technical Writer Job

HIRING: Technical Writer / Validation Specialist — West Point, PA (Onsite) — W2 or C2C (Self Corp) Contact: Anurag Kaurav (Sr. Technical Recruiter) | 📞 +1-732-401-9537 | 📧 anurag.k@vaspiretech.com Company: Vaspire Technologies Inc. | www.vaspiretech.com Type: Contract (Onsite) | Interview: Strong pipeline / fast-move 🧭 About the Role Join a GMP-regulated environment supporting documentation and validation excellence. You’ll own SOPs, user manuals, validation protocols, and regulatory submission content, and lead CSV and equipment/process validation activities aligned to 21 CFR Part 11, GAMP 5, and GxP expectations. 🛠️ Core Responsibilities Develop & maintain SOPs, User Manuals, Validation Protocols (IQ/OQ/PQ), and regulatory submission documents. Translate complex scientific/technical concepts into clear, compliant documentation. Partner with SMEs to gather/verify technical inputs; ensure traceability & accuracy. Ensure documentation aligns with GxP, ISO, and ICH standards. Manage the document lifecycle in EDMS (reviews, approvals, version control). Author and execute validation protocols for equipment, software, and processes. Perform Computer System Validation (CSV) per 21 CFR Part 11 and GAMP 5. Conduct risk assessments and support change control processes. Review/approve validation documents & final reports. ✅ Qualifications Hands-on experience in technical writing for GxP environments (pharma/biotech/medical device). Strong background in validation (IQ/OQ/PQ) and CSV (Part 11, GAMP 5). Proficiency with EDMS and controlled document workflows. Solid understanding of GxP, ISO, ICH frameworks and regulatory expectations. Excellent communication, attention to detail, and cross-functional collaboration. ⭐ Nice to Have Experience with change control, risk management tools, and audit readiness. Prior work in West Point, PA or large pharma environments. 📩 How to Apply Email your updated resume to anurag.k@vaspiretech.com with the subject: “Technical Writer / Validation Specialist – West Point, PA” Or call +1-732-401-9537 for immediate consideration. 🔖 Hashtags #HIRING #TechnicalWriter #Validation #CSV #GAMP5 #21CFRPart11 #GxP #PharmaJobs #BiotechJobs #QualityAssurance #SOPs #EDMS #Documentation #RegulatoryCompliance #ProcessValidation #PennsylvaniaJobs #Onsite #Contract #WestPointPA