Atl02_022125 Cleaning Validation Specialist_Ne

Validation & Engineering Group, Inc. (V&EG) is a leading service provider specializing in the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our expertise covers Laboratory Compliance, CSV, Engineering, Project Management, Validation, and other technical services.

We are seeking a highly skilled and dedicated professional with expertise in cleaning validation for pharmaceutical manufacturing environments. The ideal candidate will support the development, execution, and enhancement of cleaning validation programs to ensure compliance with regulatory and industry standards.

Key Responsibilities:

• Develop and execute cleaning validation protocols and Master Validation Plans (MVP) for pharmaceutical manufacturing.
• Design and implement cleaning procedures for new products and manufacturing equipment.
• Provide technical support for cleaning validation activities related to tablet manufacturing and other pharmaceutical processes.
• Investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents, deviations, and out-of-specification (OOS) results for non-validated or under-development cleaning procedures.
• Lead efforts to enhance cleaning practices, ensuring continuous improvement in cleaning validation methodologies.
• Develop, review, and approve Manufacturing Cleaning Working Instructions and Forms.
• Ensure timely resolution of incidents and deviations related to cleaning validation exercises.
• Collect and analyze validation data to support data-driven decision-making and process improvements.
• Train manufacturing and QC/QA personnel on cleaning validation documentation, procedures, and best practices.
• Maintain up-to-date knowledge of validation requirements, industry regulations, and best practices, ensuring compliance with FDA, cGMP, GxP, and OSHA guidelines.

Qualifications & Skills:

• Bachelors degree in Engineering, Chemistry, Microbiology, or a related field.
• Experience in cleaning validation for solid dosage pharmaceutical products (tablets).
• Strong knowledge of cGMP, FDA, GxP, and OSHA regulations related to cleaning validation.
• Proficiency in technical writing, including SOPs, deviations, validation protocols, and reports.
• Ability to work in a production environment and provide hands-on support for validation activities.
• Strong problem-solving skills, ability to perform data analysis, and provide data-driven recommendations.
• Proficient time management, planning, and organizational skills to manage multiple validation tasks.
• Self-starter with excellent teamwork abilities and the ability to build strong cross-functional relationships.
• Proficiency in Microsoft Office for documentation and reporting purposes.
• Excellent communication skills (English), both written and oral.