Cache of job #13828285

Job Title

Validation Engineer

Employer

ICDS Recruitment

Location

Wicklow

Description

Validation Engineer - Wicklow. Our top-end biotechnology client is looking for the ideal candidate to be their Validation Engineer, who is accountable for the following functional areas in the Quality department: Process, Facility, Software and Equipment Validations. Responsibilities: Key Team member for Process Validation,Facility Validation,Software Validation and Equipment Validation. Support and contribute to a Quality culture based upon risk management, process mastery, data-driven analytics and goal-oriented performance accountability. Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements. Understand new regulations and guidelines and implement systems and procedures to incorporate these new regulations. Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs) for functional areas under responsibility. Process ownership of Validation Systems. Ensure clear and unambiguous requirements for validation activities. Provide and support validation resources for cross-departmental projects; manage these resources within a defined project management framework. Ensure that all validation protocols and reports meet the requirements of the Quality Management System. Prepare, maintain and review Quality System documents relating to validation, (IQ, OQ, PQ, URS. Prepare and maintain Risk Assessments. Basic requirements: Degree in a science, engineering or business discipline. 2+ years' experience in in vitro diagnostics or related industry. Validation protocols and reports. Project management of cross-functional teams. Building and leading effective teams, and highly motivated individuals. The ideal candidate will: Ability to articulate and gain consensus for the Quality perspective in business decisions; provide effective solutions for key business stakeholders. Technical writing expertise in validation processes, protocols and reports. Ability to successfully implement change. Ability to collaborate with and influence groups in a positive, team-based environment. Takes a long-term view of the business to create a vision for validation functions with the Quality organization; formulates and implements effective strategies to achieve that vision. Plans, organises and prioritises resources and activities. Demonstrate the flexibility and adaptability to be successful in a changing environment. Proactively seeks and is open to alternative ideas and approaches. This job originally appeared on RecruitIreland.com.

Date Added

2330 days ago

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