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Contact Info
Brian Christensen
Life Science

+353 (0)1 685 47 47
brian.c@lifescience.ie
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Details

Principal Validation Engineer


Reference:BC/HQ00001759 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client, a Global Biopharmaceutical organisation based in South Dublin require a Principal Validation Engineer to join their growing team. The successful candidate will be required to be a Subject Matter Expert in their area of process responsibility.

Responsibilities:

•Be the site process owner for sterilisation, depyrogenation and Media Fills for Vials and syringes
•Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling.
•Leading the team in Audit Preparation to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
•Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
•Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
•Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
•Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed.
•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.
•Participate as required in project activities.
•Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
•Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
•Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.

Requirements:
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 8-10 years experience in a similar role.
• Knowledge of cGMP’s and other worldwide regulatory requirements.
• Ability to Lead a team
• Customer service
• Honesty and consistency
• Planning and prioritisation.
• Drive for results
• Creative and analytical thinking,
• Focus on quality
• Attention to detail
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747