Validation Consultant

Company : Katalyst Healthcares & Life Sciences

Job Description:

We are seeking a skilled and experienced Validation Consultant with a strong background in the pharmaceutical industry, particularly in decommissioning of facilities, equipment, and systems. The ideal candidate will work closely with cross-functional teams to ensure compliance with regulatory standards, assist in decommissioning activities, and validate systems and processes in accordance with industry best practices.

The Validation Consultant will be responsible for leading validation efforts, developing and executing validation protocols, ensuring proper decommissioning of systems, and ensuring compliance with industry regulations (e.g., FDA, EMA, ISO).

Responsibilities:

• Develop, execute, and maintain validation protocols and reports for equipment, systems, processes, and software.
• Lead qualification and validation activities for manufacturing, laboratory, and packaging systems.
• Conduct risk assessments and ensure proper risk mitigation strategies are in place.
• Provide expertise in Good Manufacturing Practice (GMP) and regulatory guidelines for validation processes.
• Perform process and equipment qualification (IQ/OQ/PQ) for new and existing systems, ensuring that they meet regulatory and quality standards.
• Oversee and support the decommissioning of pharmaceutical manufacturing facilities, equipment, and systems.
• Work with engineering and operations teams to assess equipment for decommissioning, ensuring compliance with environmental, health, and safety regulations.
• Develop decommissioning plans and coordinate the execution of decommissioning activities.
• Ensure that decommissioning activities are properly documented and validated according to regulatory requirements.
• Provide guidance on the appropriate disposal or repurposing of decommissioned equipment.
• Ensure all validation and decommissioning activities comply with industry regulations such as FDA 21 CFR Part 11, EU GMP, and ISO standards.
• Maintain accurate and thorough documentation of validation and decommissioning processes.
• Prepare and review validation master plans, validation protocols, and reports.
• Ensure all validation work is conducted in alignment with company SOPs and regulatory expectations.

Requirements:

• Bachelor's or master's degree in engineering, Life Sciences, Chemistry, or related field.
• Proven experience (typically 5+ years) in validation within the pharmaceutical industry, with a focus on equipment, systems, and process validation.
• Demonstrated experience with decommissioning of pharmaceutical facilities, equipment, and systems.
• Strong knowledge of regulatory requirements, such as FDA, EMA, ISO 13485, and GMP.
• Experience with validation lifecycle documentation (e.g., protocols, reports, and risk assessments).
• Familiarity with computerized systems validation (CSV) and data integrity principles.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work independently and as part of a cross-functional team.
• Experience in preparing and conducting audits related to validation and decommissioning activities.

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