Validation Engineer

Job Responsibilities:

• Develop, execute, and support process validation activities for pharmaceutical manufacturing processes and equipment
• Prepare and review validation documentation including protocols, reports, risk assessments, and deviation investigations
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and Regulatory Affairs
• Ensure validation activities are conducted in compliance with cGMP regulations, FDA guidelines, and internal quality standards
• Analyze validation data, identify trends, and recommend process improvements to enhance product quality and process efficiency
• Participate in Process Failure Mode and Effects Analysis (FMEA) activities to assess process and product risks
• Support cleaning validation, process validation, equipment qualification, and computerized system validation initiatives
• Troubleshoot validation-related issues and provide technical support during manufacturing operations
• Assist with implementation of new equipment, manufacturing technologies, and process improvements
• Maintain accurate validation records and ensure data integrity throughout all validation activities
• Support regulatory inspections, audits, and client requests by providing validation documentation and technical expertise
• Partner with vendors and contractors to review technical specifications and validation requirements
• Drive continuous improvement initiatives related to validation systems, compliance, and manufacturing performance
• Support ongoing monitoring and revalidation activities for validated systems and processes

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
• 3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environments
• Strong knowledge of cGMP regulations, FDA requirements, and pharmaceutical quality systems
• Experience with process validation, equipment qualification, cleaning validation, or computerized system validation
• Understanding of aseptic processing, sterile manufacturing, and pharmaceutical production operations preferred
• Familiarity with IQ/OQ/PQ protocols, deviation investigations, CAPA systems, and change controls
• Strong analytical, troubleshooting, and problem-solving abilities
• Excellent technical writing and documentation skills
• Experience working with cross-functional teams in a fast-paced manufacturing environment
• Knowledge of risk management tools such as FMEA preferred
• Lean Six Sigma certification or continuous improvement experience preferred
• Strong communication, organization, and time management skills
• Ability to manage multiple projects and priorities while maintaining attention to detail
• Proficiency with Microsoft Office and validation documentation systems preferred