Snr Cleaning Validation Engineer

2 weeks ago

Dublin, Ireland Berkley Group Full time

Overview

Snr Cleaning Validation Engineer – Pharmaceutical, Dublin – Contract

Our client are seeking a Cleaning Validation Engineer on an initial 12 month contract with the possibility of an extension on a hybrid basis. You will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.

Responsibilities

- Development of Cleaning Validation Strategy, Validation Plans, Protocols and Reports for all cleaning and sterilisation equipment and processes for a Sterile Fill Finish Facility.
- Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
- Load Configuration and cycle development Cleaning Validation and Performance Qualification.
- Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & 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 used to support Sterile Vial and Syringe Manufacturing.
- Take swabs and rinse samples and perform laboratory studies to support cleaning validation studies on site.
- Participate as required in project activities.
- Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team.
- Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
- Collate and report on relevant Validation data/matrices.
- Assist in deviation and exception resolution and root cause analysis.
- Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
- Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area
- Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and client requirements, policies and procedures

Qualifications

- A third level qualification in Science, Engineering or a relevant Quality discipline.
- Cleaning Validation Experience essential: Minimum 4-6 years experience in Cleaning Validation
- Cleanroom Experience an advantage
- Problem solving ability and excellent oral and written communications skills

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on +353 86 1263871 or send your CV to doconnell@berkley-group.com.

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