Cleaning Validation Specialist

Job Description

Salary:

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, 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:

Bachelors 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.