Job Type: Contract
Job ID: JO-1908-19241
Consultant: Karen McHugh
Do you have circa 6+ years’ experience in cleaning validation with major Pharma and Biotech manufacturing companies implementing the strategies for cleaning cycle development including; cleaning verification, syringe filling and API manufacture?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Validation Engineer - Cleaning Validation - Biotech - Dun Laoghaire - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Development of Cleaning and Sterilisation 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 and Sterilisation 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 Autoclaves, CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
Handle biological indicators and perform thermal mapping executions with Ellab and LIVEs validation hardware
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 Amgen’s requirements, policies and procedures
Minimum 4+ years overall experience in a similar role.
Cleaning and Sterilisation Experience essential (min 2 years)
A third level qualification in Science, Engineering or a relevant Quality discipline.
Candidates MUST have GMP experience in pharma/bio
Component Preparation Commissioning Experience an advantage
Problem solving ability and excellent oral and written communications skills
Honesty and consistency
Planning and prioritisation
Drive for results
Creative and analytical thinking
Focus on quality
Attention to detail
Hourly Rate €50 - €65 per hour
Minimum contract duration: 12 months
Potential to work from home
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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