Biotech Cleaning Validation Engineer

3 weeks ago


Dublin, Dublin City, Ireland JobContax Full time

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Biotech Cleaning Validation Engineer, Dublin

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Client:

JobContax

Location:

Dublin, Ireland

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3c7cab01fbdf

Job Views:

3

Posted:

24.06.2025

Expiry Date:

08.08.2025

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Job Description:

Biotech Cleaning Validation Engineer, Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:Hybrrid 2/3 days onsite per week

Experience: 5+ years

Visa:EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

As a Cleaning validation engineer, 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.

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 requirements, policies and procedures

Requirements

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

Honesty and consistency

Planning and prioritisation

Drive for results

Creative and analytical thinking

Focus on quality

Package

Minimum 12 month contract with the possibility of an extension.

Onsite expectations: When not required on site for execution, there is the potential to WFH, our team generally operates with the policy of 3+2 (ie 3 days onsite and 2 WFH days in a working week) but, again, there is flexibility involved in this at your managers discretion.

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