Senior Validation Engineer

Job Responsibilities:

• Execute qualification protocols on clean utilities, autoclaves, fillers, laboratory instruments, controlled temperature units, and other critical systems.
• Provide validation support to clients for product launches and new equipment qualifications, ensuring customer satisfaction.
• Oversee validation aspects of capital expansion projects and facility build-outs, ensuring that new installations meet regulatory requirements.
• Take ownership of creating and updating Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines related to equipment validation.
• Review facility changes and provide recommendations for re-validation and re-qualification of existing equipment based on risk assessments.
• Evaluate risks in equipment processes and review validation requirements and design deliverables to ensure compliance.
• Work closely with Engineering, Operations, and other departments to support process improvements and ongoing validation efforts.
• Conduct validation activities in accordance with approved protocols, identifying any deviations or protocol excursions and proposing corrective actions.
• Stay updated on industry trends and regulatory expectations, proposing modifications to validation programs to ensure ongoing compliance.

Qualifications:

• Bachelor’s degree or higher in a STEM discipline.
• 5-8 years of experience in validation or a related field.
• 4+ years of experience in a GMP-regulated industry.
• Strong understanding of qualification activities for equipment, utilities, and laboratory systems.