Validation Engineer

Job Responsibilities:

• Execute qualification activities for utilities, equipment, and laboratory systems, including but not limited to clean utilities, autoclaves, washers, fillers, laboratory instruments, and temperature-controlled units 
• Provide validation support to clients, particularly for new product launches and equipment qualifications
• Offer validation oversight for capital expansion projects and facility build-outs
• Assist in creating validation lifecycle documents, including templates, strategies, and policies
• Evaluate facility changes, ensuring equipment re-validation and re-qualification as necessary
• Conduct risk assessments for equipment-related processes, reviewing validation requirements and design outputs
• Collaborate closely with cross-functional teams, including Engineering and Operations, to support validation efforts and drive process improvements.
• Perform validations according to approved protocols, addressing any deviations or protocol issues as they arise

Qualifications:

• Bachelor’s degree or higher in a STEM discipline
• 2-4 years of experience in validation or a related field
• 2+ years of experience in a GMP-regulated industry