Cleaning Validation Specialist

Job Description:

• Cleaning Validation Expertise: The primary responsibility of the Cleaning Validation Specialist is to develop, execute, and oversee cleaning validation protocols for pharmaceutical solid, semi solid, liquid, cream and gel equipment and processes.
• Develop and implement cleaning Standard Operating Procedure for new equipment.
• Perform risk assessments to identify critical cleaning parameters and potential residues.
• Design and execute sampling plans to verify cleaning effectiveness.
• Analyze and interpret cleaning validation data using statistical methods.
• Author technical reports and present findings to cross-functional teams.
• Collaborate with production, quality assurance, and production departments to optimize cleaning processes.
• Ensure compliance with cGMP regulations and company standards for cleaning validation.
• Troubleshoot and investigate cleaning-related issues in manufacturing.
• Train personnel on proper cleaning techniques and validation procedures.
• Stay current with industry trends and regulatory requirements in cleaning validation.
• Subject Matter Expertise: The candidates will be expected to discuss cleaning validation matters in-depth during interviews, demonstrating their ability to run programs and act as subject matter experts in the field.

Requirements:

• A Bachelor's degree or higher in a relevant field.
• 4-5 years of extensive experience in Cleaning Validation within the pharmaceutical sectors or biotech.
• Strong hands-on experience with cleaning validation protocols and processes.
• In-depth knowledge of industry regulations and best practices.
• Excellent communication and teamwork skills.
• On-site availability is a strict requirement for this role.

Education and Experience:

• A Bachelor s in Chemical Engineering preferred
• Proficiency with statistics (using JMP or Minitab) preferred
• Experience using Excel for data mining and analysis is must
• Experience with oral solids or liquid manufacturing preferred

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.

Physical Requirements:

• Able to work flexible and extended hours including weekend.