Validation Engineer

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Company: Katalyst HealthCares and Life Sciences

Location: Richmond, VA 23223

Description:

Responsibilities:
  • Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications.
  • Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging.
  • Regularly revalidate equipment and processes when changes occur, such as new materials, changes in equipment, or regulatory updates.
  • ssess risks related to equipment, processes, and production areas that could affect product quality, safety, or compliance.
  • When risks are identified (e.g., equipment malfunctions or process deviations), implement corrective and preventive actions (CAPA) to address these issues and ensure the manufacturing process remains in compliance.
  • Write, review, and execute validation protocols for new equipment, systems, or processes, ensuring that all documentation meets regulatory and internal requirements.
  • Ensure that all validation documentation is properly archived and readily accessible for audits or regulatory inspections. This includes validation reports, test results, and any related corrective action reports.
  • Document any changes in manufacturing processes or equipment, ensuring that these changes undergo proper validation before implementation.
  • Provide training to production teams on new validated processes or equipment and on maintaining compliance with regulatory and quality standards.
Requirements:
  • bachelor's degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
  • 3-7 years of Quality / relevant process experience in regulatory environment
  • Strong communication skills to interact with cross-functional teams, senior management, and external auditors or regulators.
  • Familiarity with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems may be beneficial.
  • Strong understanding of validation methodologies, including IQ/OQ/PQ protocols, risk assessments, and data analysis techniques.
  • In-depth knowledge of Food/Consumer industry regulations, as well as FDA and GMP guidelines.
  • bility to lead and manage an onshore and offshore team.

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