Cleaning Validation Engineer

Job Title : Cleaning Validation Engineer

Strictly No C2C

Job Summary :

We are seeking a skilled Cleaning Validation Engineer with 3-5 years of experience to join our pharmaceutical team. The ideal candidate will have strong experience in CIP (Clean-in-Place) and SIP (Sterilize-in-Place) systems, along with expertise in developing, executing, and validating cleaning procedures in compliance with GMP standards.

The role involves ensuring that cleaning processes and equipment are effective, efficient, and compliant with regulatory requirements.

Key Responsibilities :

• Develop, execute, and document cleaning validation protocols for CIP and SIP systems used in pharmaceutical manufacturing.
• Lead cleaning validation activities for equipment, facilities, and manufacturing processes, ensuring compliance with FDA , EMA , and other regulatory bodies.
• Design and conduct cleaning validation studies, including swab sampling, rinse sampling, and analytical testing to ensure product quality and equipment cleanliness.
• Perform risk assessments and determine appropriate acceptance criteria for cleaning validation studies based on scientific rationale.
• Troubleshoot and optimize cleaning processes to improve efficiency and ensure robust validation outcomes.
• Collaborate with cross-functional teams including manufacturing, quality assurance, and engineering to support cleaning validation initiatives.
• Prepare detailed technical reports, validation protocols, and validation summary reports in accordance with GMP and SOP requirements.
• Ensure proper documentation and records management for all validation activities, including data analysis and trend reviews.
• Monitor ongoing cleaning validation programs, including periodic re-validation and routine verification to maintain compliance.
• Support audits and inspections by regulatory agencies and internal quality teams related to cleaning validation activities.

Qualifications :

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3-5 years of experience in cleaning validation within the pharmaceutical or biotech industry.
• Hands-on experience with CIP and SIP systems in a GMP-regulated environment.
• Strong knowledge of FDA , EMA , ICH Q7 , and GMP regulations and guidelines related to cleaning validation.
• Proficiency in writing validation protocols, technical reports, and risk assessments.
• Experience with swab and rinse sampling, analytical methods, and microbiological testing.
• Excellent problem-solving, analytical, and project management skills.
• Ability to work collaboratively in cross-functional teams and communicate effectively.
• Familiarity with quality systems, change control processes, and deviation management.

Preferred Skills :

• Experience with biopharmaceutical or sterile manufacturing environments.
• Knowledge of cleaning agent selection and their impact on product quality.
• Understanding of process validation and equipment qualification .
2 days ago