Senior Engineer Validation Specialist

Baxter seeks a Senior Engineer Validation Specialist to lead process engineering, validation, and maintenance projects in a pharmaceutical manufacturing environment in Puerto Rico. The role involves managing technical upgrades, ensuring regulatory compliance, and mentoring team members while driving operational efficiency.

Responsibilities

• Plan, organize, and oversee engineering maintenance and process upgrade projects within assigned area
• Coordinate technical activities, design changes, specifications, and resolve engineering problems
• Develop and implement procedures ensuring cGMP, safety, and FDA regulatory compliance
• Audit assigned areas for compliance with specifications, SOPs, and regulatory requirements
• Provide technical troubleshooting support and mentoring to equipment and personnel

Requirements

• Bachelor's degree in Engineering or Sciences with minimum 5 years manufacturing experience
• Expertise in product development, change control, validations, or related areas
• Master's degree or PhD with 1-2 years experience acceptable as equivalent
• Strong project management and budget control capabilities
• Knowledge of cGMP, cGDP, FDA regulations, and quality compliance standards
• Proven supervisory and cross-functional communication skills
• Willingness to work variable shifts and travel as needed