Validation Engineer

Summary:

This role involves leading and executing commissioning, qualification, and validation activities for manufacturing support facilities, utilities, systems, and equipment. It also includes responsibilities in change management, quality management systems, and supporting inspections during audits.

Responsibilities:

• Leading validation activities and managing change assessments.
• Developing and maintaining validation programs and plans.
• Supporting and leading cross-functional teams in validation efforts.
• Handling quality management activities like CAPAs, deviations, and risk assessments.
• Participating in hazardous waste training and responding to spills.

Skills and Abilities:

• Strong organizational and project management skills.
• Effective troubleshooting and problem-solving abilities.
• Proficiency in GMP regulations and validation processes.
• Excellent communication skills and the ability to lead multiple projects.

Core Values:

• High ethical standards and compliance.
• Ownership of actions and outcomes.
• Respect and collaboration.
• Commitment to excellence and patient care.
• Enthusiasm for change and continuous improvement.

Education & Experience:

• Bachelor’s degree in an engineering or science-related field.
• At least 5 years of experience in the pharmaceutical industry, with 3 years in validation.
• Knowledge of current validation principles and GMP regulations.