Cleaning Validation Engineer

Reports to: Validation Manager

Are you an experienced Cleaning Validation Engineer looking to make a significant impact in a state-of-the-art sterile manufacturing facility? We're seeking a dedicated professional to ensure our cleaning and sterilization validation activities meet the highest industry standards and regulatory requirements.

About the Role

This is a critical role in maintaining the quality and safety of our products.

• Develop comprehensive Cleaning Validation Strategies, Validation Plans, Protocols, and Reports for all cleaning and sterilization equipment and processes within our Sterile Fill Finish Facility.
• Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
• Lead Load Configuration and cycle development for Cleaning Validation and Performance Qualification.
• Confirm that the site consistently meets the quality requirements of its customers and applicable regulations from FDA, EU, and other International Standards.
• Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective for CIP, COP, Parts Washers, and Ultrasonic Baths supporting Sterile Vial and Syringe Manufacturing.
• Take swabs and rinse samples and conduct laboratory studies to support on-site cleaning validation studies.
• Participate in relevant project activities and multidisciplinary site/multisite teams, such as cross-functional investigation teams.
• Contribute to the ongoing development of existing Validation programs to ensure continued regulatory compliance, providing input to Site Validation Guidance Documents.
• Collate and report on relevant Validation data and metrics.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and roll out Validation Training programs for the site.
• Comply with all site safety statements and champion safe working practices.
• Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and company policies.

• A third-level qualification in Science, Engineering, or a relevant Quality discipline is essential.
• Minimum of 4-6 years of experience in Cleaning Validation is essential.
• Cleanroom experience is an advantage.
• Demonstrated problem-solving ability and excellent oral and written communication skills.

• Strong customer service orientation.
• Honesty and consistency in work.
• Excellent planning and prioritization skills.
• A drive for results with a focus on quality.
• Creative and analytical thinking.
• Exceptional attention to detail.