Job Description
A Validation Engineer is required by Careerwise recruitment to work with our Clare based pharmaceutical client.
Role of this position
Effectively working within a multidisciplinary team to prepare, schedule and execute Commissioning, Qualification and Validation protocols.
Lead Risk assessments for process and equipment as required.
Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors.
Develop protocols for validation projects that meet regulatory requirements and industry practices.
JOB REQUIREMENTS
BSc/MSc or BEng/MEng in Engineering or related discipline.
5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof.
Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
Validation experience using risk-based approach guidelines, international regulatory requirements and standards.
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