Cleaning Validation Specialist

Moriah Engineering; Jayuya (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Moriah Engineering is seeking a Cleaning Validation Specialist to develop, execute, and manage cleaning validation activities across manufacturing equipment and utilities. The role emphasizes regulatory compliance, risk assessment, data analysis, and cross-functional collaboration with QA, manufacturing, and engineering teams.

Responsibilities include planning and performing validation activities for compressed air systems, maintaining documentation, and supporting audits.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Microbiology, or related field.
• 2+ years of experience in cleaning validation within a regulated manufacturing environment.
• Experience in utilities qualification, especially compressed air systems.
• Strong knowledge of GMP, FDA, and ICH guidelines.
• Proficiency in developing and executing cleaning validation protocols and reports.
• Demonstrated experience in risk assessment and data analysis for cleaning validation.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills for cross-functional collaboration.

Responsibilities

• Develop and implement cleaning validation protocols and reports in line with GMP and regulatory standards.
• Plan and execute cleaning validation for manufacturing equipment and utilities, including compressed air systems.
• Conduct risk assessments and identify critical control points for validation activities.
• Perform sampling and testing of cleaned equipment and utilities against acceptance criteria.
• Collaborate with QA, Manufacturing, and Engineering to define validation requirements and processes.
• Develop protocols for utilities qualification and monitoring, focusing on compressed air systems.
• Analyze data to identify trends and propose improvements for cleaning and utilities validation.
• Manage deviations/non-conformances and ensure timely investigations and resolutions.
• Maintain detailed documentation of validation activities and ensure consistent implementation.
• Support audits/inspections with expertise in cleaning validation and utilities processes.
• Stay updated on industry trends and regulatory changes to ensure ongoing compliance.

Skills

Cleaning validation

Risk assessment

Data analysis

Cross-functional collaboration

Problem-solving

Communication

Education

Bachelor's degree in Engineering/ Chemistry/ Microbiology

Tools

MS Excel

MS Word

PowerPoint

Project management tools

Job description

Job Summary

The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes to particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.

Responsibilities

• Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.
• Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.
• Conduct risk assessments and identify critical control points for cleaning validation.
• Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.
• Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.
• Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.
• Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.
• Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.
• Ensure the consistent implementation of cleaning validation processes across manufacturing operations.
• Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.
• Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.

Qualifications

• Bachelor's Degree in Engineering, Chemistry, Microbiology, or a related field.
• 2+ years of experience in cleaning validation within a regulated manufacturing environment.
• Experience in utilities qualification, particularly compressed air systems.
• Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.
• Proficiency in developing and executing cleaning validation protocols and reports.
• Demonstrated experience in risk assessment and data analysis for cleaning validation.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.
• Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.

Physical/Mental Requirements

• Ability to work in a manufacturing environment, including cleanrooms and production areas.
• Able to stand for extended periods and climb ladders/steps as needed.
• Ability to lift and move items up to 25 lbs.

About the Company

We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.