Senior Cleaning Validation Professional

hace 4 semanas

Manatí, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

Job Summary

The Senior Cleaning Validation Professional is responsible for ensuring that cleaning processes meet regulatory standards, preventing contamination and ensuring product safety and quality. This role involves developing, executing, and documenting cleaning validation protocols in compliance with FDA, EU GMP, and other applicable guidelines.

Key Responsibilities:
  • Develop Cleaning Validation Plans: Draft and review cleaning validation master plans, protocols, and reports. Define acceptance criteria for residue limits, microbial limits, and analytical methods.
  • Execute Cleaning Validation Protocols: Coordinate and conduct validation studies, including swab sampling, rinse sampling, and analytical testing. Collect and analyze data to ensure equipment cleaning processes meet predefined standards.
  • Documentation: Prepare and maintain detailed validation reports and logs. Ensure all validation documentation is accurate and compliant with regulatory requirements.
  • Regulatory Compliance: Stay updated on industry standards (e.g., FDA, ICH, EU GMP). Ensure validation activities align with regulatory guidelines and company policies.
  • Risk Assessment: Perform risk assessments related to cleaning procedures and potential cross-contamination. Identify critical cleaning parameters and monitor them for continued compliance.
  • Cross-Functional Collaboration: Work closely with manufacturing, quality control, and engineering teams to optimize cleaning procedures. Provide training to relevant personnel on cleaning validation procedures and regulatory requirements.
  • Troubleshooting and Continuous Improvement: Investigate deviations or failures in cleaning processes and recommend corrective actions. Continuously evaluate and improve cleaning validation practices for efficiency and compliance.

Qualifications:

  • Education: Bachelor's degree in Chemistry, Biology, Engineering, or related field (Master's preferred).
  • Experience: Minimum of 3–5 years of experience in cleaning validation or related roles in the pharmaceutical or biotech industry. Experience with regulatory inspections and audits is highly desirable.
  • Skills and Competencies: In-depth knowledge of cleaning validation principles, regulatory guidelines, and analytical methods. Proficiency in using analytical instruments like HPLC, TOC analyzers, and microbiological testing methods. Strong problem-solving, analytical, and critical-thinking skills. Excellent organizational and communication skills.

Compensation: The estimated annual salary for this position is around $80,000-$110,000 depending on experience and location.

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