Cleaning Validation
About this role
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.
Essential Functions
- Develops and approves validation deliverables, which comply with regulatory guidelines and business requirements. Represent 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.
Physical Demands and Work Environment
- The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Other Duties
Duties, responsibilities, and activities may change at any time with or without notice.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
Company at a glance
MedPharm is a specialized CDMO focused on the development, testing, and manufacture of topical and transepithelial drug products.
We partner with pharmaceutical and biotechnology companies to advance innovative therapies from early development through clinical and commercial manufacturing. Our integrated capabilities span formulation development, analytical and bioanalytical testing, research biology, IVRT and IVPT studies, clinical trial material manufacturing, scale-up, and commercial manufacturing.
With expertise across multiple routes of delivery, including skin, nail, eye, respiratory (nasal and lung), and mucosal applications, MedPharm helps sponsors overcome complex development challenges and generate the data needed to make confident decisions throughout the product lifecycle.
Backed by more than 25 years of experience, specialized research models, and deep regulatory expertise, we combine scientific insight with practical execution to help accelerate development and support successful commercialization.
From concept to commercialization, MedPharm helps transform promising drug products into patient-ready therapies.
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