Cleaning Validation Engineer

Ultimate Solutions Corp; Puerto Rico; On-site; COP 291,281,000 - 420,739,000; Full time

Job summary

Ultimate Solutions Corp. 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.

Qualifications

• Bachelor’s degree in Engineering is required (Chemical, Mechanical, Industrial, Biomedical, or related).
• Experience in Cleaning Validation within the pharmaceutical or regulated Life Sciences industry.
• Experience with cleaning validation of product contact surfaces and/or components.
• Experience developing, reviewing, and executing validation protocols and reports.
• Knowledge of swab and/or rinse sampling methodologies.
• Knowledge of GMP requirements and validation practices.
• Strong technical writing, documentation, analytical, and problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Bilingual proficiency in English and Spanish preferred.

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 Manufacturing, Quality, Engineering, Validation, and Laboratory personnel during planning and execution.
• Ensure activities and documentation comply with applicable GMP requirements and site procedures.
• Prepare accurate and complete validation documentation, including protocols, execution records, and final reports.

Skills

Technical writing

Documentation

Analytical

Problem solving

Education

Bachelor’s degree in Engineering

Job description

Ultimate Solutions Corp. is a global 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 Manufacturing, Quality, Engineering, Validation, and Laboratory personnel during planning and execution.
• Ensure activities and documentation comply with applicable GMP requirements and site procedures.
• Prepare accurate and complete validation documentation, including protocols, execution records, and final reports.

Qualifications

• Bachelor’s degree in Engineering is required (Chemical, Mechanical, Industrial, Biomedical, or related Engineering discipline).
• Experience in Cleaning Validation within the pharmaceutical or regulated Life Sciences industry.
• Experience with cleaning validation of product contact surfaces and/or components.
• Experience developing, reviewing, and executing validation protocols and reports.
• Knowledge of swab and/or rinse sampling methodologies.
• Knowledge of GMP requirements and validation practices.
• Strong technical writing, documentation, analytical, and problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Bilingual proficiency in English and Spanish preferred.

Ultimate Solutions Corp. is an Equal Opportunity Employer.