Cleaning Validation Specialist - SME

United Pharma; Kentucky; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma in Kentucky is seeking an experienced Cleaning SME to support pharmaceutical cleaning validation efforts in a GMP-regulated manufacturing environment. The role focuses on developing and reviewing cleaning validation documentation, establishing robust strategies, and resolving validation-related challenges to ensure compliant operations.

You will collaborate with Manufacturing, QA, Validation, and Engineering teams to troubleshoot issues, review protocols, and implement effective

Qualifications

• Pharma-cleaning validation experience required.
• Strong GMP knowledge and documentation practices.
• Ability to troubleshoot validation issues and implement corrective actions.
• Experience developing and reviewing validation protocols and reports.

Responsibilities

• Provide SME guidance on cleaning processes and validation activities in pharma manufacturing.
• Support equipment and process cleaning per GMP and procedures.
• Develop, review, and execute cleaning validation protocols and reports.
• Identify worst-case products/equipment to set cleaning strategies.
• Evaluate procedures to ensure suitability for equipment and processes.
• Troubleshoot validation issues and recommend corrective actions.
• Collaborate with Manufacturing, QA, Validation, and Engineering teams to resolve challenges.

Skills

Cleaning validation

GMP compliance

Documentation

Troubleshooting

Cross-functional collaboration

Job description

Seeking an experienced Cleaning SME / Cleaning Validation Specialist to support a leading pharmaceutical manufacturing organization. The ideal candidate will bring strong expertise in pharmaceutical cleaning processes, cleaning validation, GMP compliance, and technical troubleshooting. This role will focus on developing and reviewing cleaning validation documentation, establishing appropriate cleaning strategies, and resolving cleaning-related challenges to support compliant manufacturing operations.

Key Responsibilities:

• Provide subject matter expertise in cleaning processes and cleaning validation activities within a pharmaceutical manufacturing environment.
• Support equipment and process cleaning activities in accordance with GMP requirements and established procedures.
• Develop, review, and support the execution of cleaning validation protocols, reports, and associated documentation.
• Identify and assess worst-case products, equipment, and manufacturing conditions to establish appropriate cleaning strategies.
• Evaluate cleaning procedures and validation approaches to ensure they are suitable for the intended equipment and processes.
• Troubleshoot cleaning validation issues, investigate potential causes, and recommend effective corrective actions.
• Collaborate with Manufacturing, Quality Assurance, Validation, and Engineering teams to address cleaning-related challenges.

Key Skills & Qualifications:

• Strong hands-on experience in cleaning validation and pharmaceutical cleaning processes.
• Experience with equipment and process cleaning in a GMP-regulated environment.
• Proven ability to develop and review cleaning validation protocols and reports.
• Knowledge of worst-case product selection, equipment assessment, and cleaning strategy development.
• Experience troubleshooting cleaning validation issues and implementing appropriate solutions.
• Understanding of GMP requirements, validation principles, and pharmaceutical manufacturing practices.
• Strong technical documentation, analytical, problem-solving, and cross-functional collaboration skills.