We are seeking an experienced Validation Manager to lead and execute validation and qualification programs across a dynamic manufacturing facility specializing in pharmaceutical and personal care products. This role will ensure compliance with applicable regulatory standards while supporting cross-functional teams to optimize manufacturing processes.

Key Responsibilities:

🔹 Validation Strategy & Execution

• Develop and maintain comprehensive Validation Master Plans for the site.
• Plan, execute, and document Facility, Utility, and Equipment Qualifications.
• Conduct Process Validations and Performance Qualifications.
• Implement and sustain robust Cleaning and Computer System Validation programs.

🔹 Process & Quality Support

• Collaborate with Engineering, QA, and Production teams in conducting pFMEAs.
• Assist in process trials, pilot batches, and validation activities for new formulations.
• Develop and maintain SOPs; provide training to relevant stakeholders.
• Lead multiple validation projects, ensuring timely completion and quality standards.
• Present reports and updates to leadership and cross-functional teams.

🔹 Compliance & Technical Leadership

• Ensure all validation efforts comply with cGMP, FDA regulations, and applicable OTC standards.
• Participate in internal/external audits, conduct risk assessments, and support CAPA initiatives.
• Provide technical support for new equipment selection, installation, and documentation development.

Required Skills & Qualifications:

• Deep understanding of Facility, Utility, Equipment, Cleaning, and Computer System Validation.
• Proven knowledge of Process Performance Qualification and associated compliance standards.
• Experience with regulatory audits and quality systems in a manufacturing environment.
• Ability to lead validation projects with cross-functional coordination and strong communication.
• Excellent problem-solving, critical thinking, and organizational skills.
• Proficiency with Microsoft Office and technical documentation.