We are seeking an experienced Validation Engineer specializing in lyophilization processes and equipment. The ideal candidate will lead validation activities, ensuring compliance with regulatory standards while supporting manufacturing excellence in a pharmaceutical or biotech setting.

Key Responsibilities:

• Develop and execute validation protocols for lyophilization equipment and processes.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for lyophilizers.
• Create, review, and maintain validation documentation, including protocols, reports, and risk assessments.
• Conduct validation testing to meet regulatory and industry compliance standards.
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing.
• Address validation issues and implement corrective and preventive actions (CAPA).
• Stay updated on industry trends and regulatory changes related to lyophilization and validation.
• Participate in audits concerning validation processes.
• Provide training and guidance on validation protocols and best practices.

Qualifications:

• Bachelors degree in Engineering, Life Sciences, or a related field.
• Extensive experience in lyophilization validation within the pharmaceutical or biotech industry.
• Strong understanding of GMP and regulatory requirements for equipment validation.
• Excellent analytical and problem-solving skills.
• Outstanding communication and team collaboration abilities.

Preferred Skills:

• Experience with computerized system validation (CSV).
• Familiarity with validation software tools.
• Certification in validation engineering or related disciplines.
• Knowledge of Lean or Six Sigma methodologies.