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  • 2 weeks ago

jobs description

Senior Validation Engineer

A world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries are looking for a Validation Engineer .

Essential Duties and Responsibilities:
• Responsible for DQ, IQ, OQ, PQ, CV and PV following validation plans and complying with cGMP.
• Drafting of validation protocols and finalizing of reports.
• Maintain site validation procedures and relevant SOPs for shipping, cleaning and process validation.
• Mentoring / coaching of junior team members.

Requirements:
• A bachelor's degree in Engineering, Science, or relevant Quality Discipline.
• Knowledge of 21 CFR 210/211, 21 CFR Part 11 and European regulations associated with the pharmaceutical industry.
• Strong understanding of cGMP, compliance, validation practices including the system life cycle and regulatory expectations.
• Organizational skills for concurrent execution of multiple equipment/instrument... facility and utility qualifications and projects.
• Project management skills are desirable.
• Experience with validation for sterile environments, equipment/instrument, facility and utility.
• Familiar with Shipping Validation, Cleaning Validation and Process Validation.
• Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved validation plan and protocols.
• Provides information on relevant regulations and internal validation policy with regards to equipment/instrument, facility, utility and process validations.
• Provides assistance and ensures the preparation of validation protocols, design specifications and associated documentation for equipment, systems and processes.
• Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.

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 Fred Chesne on +353 (0) 85 178 6539 or send your CV to fchesne@berkley-group.com
Dundalk County Louth Ireland

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