Cleaning Validation

MedPharm • Durham, NC

9d

About The Position

The cleaning validation position will be responsible for developing, maintaining, and approving the cleaning validation requirements ensuring compliance to the applicable business and regulatory standards. Develop and maintains site cleaning and cleaning validation processes from product development through product lifecycle. Review and approve the cleaning procedures and support the process to educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling. Defines testing strategies and document the performance and compliance of the cleaning validation program. Interfaces with regulatory inspections, investigations and site projects.

Requirements

• Developing, maintaining, and approving cleaning validation requirements.
• Ensuring compliance with applicable business and regulatory standards.
• Developing and maintaining site cleaning and cleaning validation processes from product development through product lifecycle.
• Reviewing and approving cleaning procedures.
• Educating personnel on cleaning expectations and intent.
• Defining testing strategies.
• Documenting the performance and compliance of the cleaning validation program.
• Interfacing with regulatory inspections, investigations, and site projects.
• Training employees on procedures and process effectiveness.
• Establishing and/or participating in the creation of policies, procedures, guidelines, and templates in validation.
• Managing the testing approach and cleaning swab sample locations on new equipment and/or for new products.
• Mentoring and training Cleaning Validation colleagues on policies and procedures.

Responsibilities

• Develops and approves validation deliverables, which comply with regulatory guidelines and business requirements.
• Represents CV during regulatory inspections.
• Conduct periodic reviews of the compliance of cleaning processes to the validated state and to ensure the effectiveness of the cleaning validation program.
• Revise and approve procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions.
• Support the implementation of the optimization and improvements in a consistency and effectiveness ways of cleaning processes.
• Support employee training to ensure compliance to procedure and process effectiveness.
• Establishes and/or participates in the creation of policies, procedures, guidelines, and templates in the area of validation.
• Provide leadership and direction to manage the testing approach and cleaning swab sample locations on new equipment and/or for new products, with the appropriate direction on the alignment with the philosophy defined by the Cleaning Validation engineering team.
• Lead, define and manage the mentoring and training of Cleaning Validation colleagues on policies and procedures including the cleaning validation process.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed