Technical Writer Job

Hiring :  Technical Writer/Validation Specialist (Life Sciences) - West Point, PA

Job Title -  Technical Writer/Validation Specialist Location -  West Point, PA Experience - 8+ Note : NO GC and NO H1B (USC preferred)

Job Description: -Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents. -Translate complex scientific and technical concepts into clear, concise documentation. -Collaborate with SMEs to gather and verify technical information. -Ensure documentation complies with industry standards (GxP, ISO, ICH). -Manage document lifecycle using electronic document management systems (EDMS). -Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes. -Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5. -Conduct risk assessments and support change control processes. -Review and approve validation documentation and reports.

Vinayak Soni US IT Recruiter, KTEK Resourcing E vinayak.soni@ktekresourcing.com +18327619184

Abhishek Soni Harshit Solanki