SME Cleaning Validation Specialist

Job Title: SME Cleaning Validation Specialist (Drug Product)

Location: East of Puerto Rico (Open to Puerto Rico residents)

Period: Aproximately One Year.

Job Summary:

ProQuality Network is seeking a Subject Matter Expert in Validation with Technical Transfer experience for new products to work on a contractual basis with our client in a drug substance pharmaceutical operations. The selected candidate will play a critical role in ensuring compliance with industry regulations and best practices in cleaning validation processes.

Responsibilities:

• Able to conduct audits of validation studies in compliance with Drug Substance pharmaceutical industry. 
• The audits includes the revision of existing validation plans, executions, deviations, change controls and reports associated to the project.  
• Perform GAP Assessments to identify and address deficiencies in cleaning validation processes.
• Conduct internal and external audits to ensure regulatory and procedural compliance.
• Serve as a Subject Matter Expert (SME) in cleaning validation, providing technical guidance and support.
• The Subject Matter Expert will generate a Validation Summary Report for the products.
• Execute cleaning validation processes, ensuring compliance with regulatory requirements and industry best practices.

Qualifications:

• Bachelor’s degree in Engineering or Science, or a related field.
• 7+ years of hands-on experience in cleaning validation, Technical Transfer for New Products within a regulated drug product environment.
• Experience conducting GAP Assessments, audits, and validation execution.
• Ability to interpret and apply industry regulations and guidelines.
• Excellent problem-solving and analytical skills.

This is a contract position through ProQuality Network for a client in a regulated pharmaceutical environment.

Interested candidates are encouraged to apply by submitting an updated resume through the job description link.