11 oct
|
Ultimate Solutions
|
Puerto Rico
11 oct
Ultimate Solutions
Puerto Rico
Ultimate Solutions Corp. is a general leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 21 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide.
Job Summary
Ultimate Solutions is seeking a Cleaning Validation Engineer to support cleaning validation activities within a regulated pharmaceutical manufacturing environment. The selected candidate will be responsible for the development, execution, and documentation of cleaning validation activities associated with product contact surfaces and components, ensuring compliance with applicable GMP requirements, approved procedures, and site validation standards.
Key Responsibilities
- Develop, review, and execute Cleaning Validation protocols and reports for product contact surfaces and components.
- Support cleaning validation activities for manufacturing equipment, components, and associated product contact surfaces.
- Perform and/or support equipment and product contact surface assessments to determine applicable cleaning validation requirements.
- Support swab and rinse sampling activities, as applicable.
- Review cleaning validation results against established acceptance criteria.
- Support evaluation of worst-case conditions, products, equipment, and components, as applicable.
- Support cleaning validation lifecycle activities, including initial validation, revalidation, and assessment of changes impacting the validated state.
- Investigate and document deviations or discrepancies identified during validation activities.
- Support CAPA and Change Control activities related to cleaning validation.
- Review applicable procedures, specifications, equipment documentation, and validation documentation.
- Collaborate with
📌 Cleaning Validation Engineer (Puerto Rico)
🏢 Ultimate Solutions
📍 Puerto Rico