Validation Engineer II

We are looking for a highly detail-oriented and self-driven Documentation & Quality Systems Specialist to join our team. The ideal candidate will possess exceptional documentation skills, strong analytical thinking, and the ability to independently drive assignments from initiation through completion.

This role requires someone who is disciplined in documentation practices, experienced with quality systems, and capable of troubleshooting technical or process-related issues while maintaining compliance and accuracy across all records and reports.

Key Responsibilities

• Prepare, review, and maintain high-quality technical documentation, reports, SOPs, work instructions, and process records.
• Ensure all documentation complies with internal quality standards, regulatory requirements, and documentation best practices.
• Independently manage assignments end-to-end, including documentation, investigation, troubleshooting, follow-up, and closure.
• Investigate process deviations, identify root causes, and support corrective and preventive actions (CAPA).
• Collaborate cross-functionally with operations, engineering, quality, and support teams to gather information and resolve issues efficiently.
• Maintain accurate records and ensure version control, traceability, and documentation integrity.
• Support audits, inspections, and quality reviews by preparing and organizing required documentation.
• Drive continuous improvement initiatives related to documentation processes, quality compliance, and operational efficiency.
• Ensure strict adherence to Good Documentation Practices (GDP) and quality system procedures at all times.
• Analyze problems systematically and provide practical, well-documented solutions.
  
  

Required Skills & Qualifications

• Strong documentation and technical writing skills with exceptional attention to detail.
• Proven ability to independently handle tasks from beginning to end with minimal supervision.
• Excellent troubleshooting and problem-solving capabilities.
• Experience working within Quality Management Systems (QMS) or regulated environments.
• Strong understanding of Good Documentation Practices (GDP).
• Ability to maintain organized, accurate, and audit-ready documentation.
• Effective communication and collaboration skills.
• Strong analytical mindset with the ability to identify process gaps and recommend improvements.
• Proficiency in Microsoft Office tools and documentation management systems.
  
  

Preferred Qualifications

• Experience in manufacturing, pharmaceuticals, medical devices, engineering, healthcare, or regulated industries.
• Familiarity with CAPA, deviation handling, change control, and audit processes.
• Knowledge of ISO, GMP, FDA, or other quality/compliance standards is an advantage.