Validation Engineer

Validation Engineer

The Validation Engineer is responsible for developing, implementing, and executing test method validations while ensuring compliance with internal quality standards and regulatory requirements. This role includes creating validation documentation, managing validation protocols, supporting change management activities, and collaborating with cross-functional teams throughout the validation lifecycle.

• Create and execute test method validation protocols.
• Develop validation documentation for manufacturing processes, systems, and equipment.
• Manage Validation Master Plans (VMPs) and associated validation documentation.
• Execute validation protocols and evaluate validation results.
• Prepare comprehensive validation summary reports.
• Review and assess validation impacts related to change management activities.
• Track validation project progress and maintain project documentation.
• Ensure validation activities comply with quality system requirements and applicable regulatory standards.
• Participate in internal and external quality audits related to validation projects.
• Collaborate with engineering, manufacturing, quality, and other cross-functional teams.
• Lead validation projects of moderate scope and provide technical guidance to junior team members.
• Mentor less experienced engineers and support continuous improvement initiatives.
• Prioritize multiple assignments while meeting project timelines and quality objectives.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or an equivalent combination of education and experience.
• Minimum five years of validation, quality, manufacturing, or related engineering experience.
• Strong understanding of validation principles, quality systems, and regulated manufacturing environments.
• Experience developing validation protocols, reports, and supporting documentation.
• Knowledge of production processes, change management, and validation lifecycle activities.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating with cross-functional teams.

• Master's degree in a related field.
• Experience supporting new product development and production process validation.
• Experience participating in regulatory or quality audits.
• Knowledge of quality management systems and regulatory compliance requirements.
• Previous experience leading validation projects and mentoring junior engineers.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.