Location: Dublin
Department: Validation
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
As a Cleaning Validation Engineer, you'll be responsible for ensuring that all cleaning validation activities associated with our Sterile Vial and Syringe Manufacturing Facility are in full compliance with our Division Quality System requirements and recognized international standards. This is a critical role in maintaining the quality and safety of our products.
Key Responsibilities
- 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.
Experience & Background
- 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.
Key Competencies
- 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.
