Cleaning Validation
On-siteDurham, North Carolina, United States
Job Summary
Develop and maintain site cleaning and cleaning validation processes from product development through the product lifecycle. Approve cleaning procedures, define testing strategies, and document performance and compliance of the cleaning validation program. Conduct periodic reviews of the compliance of cleaning processes to ensure the effectiveness of the program. Represent the position during regulatory inspections and investigations. Lead mentoring and training of colleagues on policies, procedures, and the cleaning validation process. Establish policies, guidelines, and templates for validation, including directing swab sample locations for new equipment or products.
Required Qualifications
- Experience in developing, maintaining, and approving cleaning validation requirements ensuring compliance to applicable business and regulatory standards
- Ability to develop and maintain site cleaning and cleaning validation processes from product development through product lifecycle
- Capability to review and approve cleaning procedures
- Ability to support the process to educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling
- Skill in defining testing strategies and documenting the performance and compliance of the cleaning validation program
- Experience interfacing with regulatory inspections, investigations, and site projects
- Ability to develop and approve validation deliverables complying with regulatory guidelines and business requirements
- Capability to represent CV during regulatory inspections
- Skill in conducting periodic reviews of the compliance of cleaning processes to the validated state and ensuring the effectiveness of the cleaning validation program
- Ability to revise and approve procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions
- Experience supporting the implementation of optimization and improvements in cleaning processes
- Capability to support employee training to ensure compliance to procedure and process effectiveness
- Skill in establishing and/or participating in the creation of policies, procedures, guidelines, and templates in the area of validation
- Ability to provide leadership and direction to manage the testing approach and cleaning swab sample locations on new equipment and/or for new products
- Experience with alignment with the philosophy defined by the Cleaning Validation engineering team
- Capability to lead, define, and manage the mentoring and training of Cleaning Validation colleagues on policies and procedures including the cleaning validation process
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