- BBBH779514 May 28, 2021 Competitive
One of Ireland's largest manufacturing facilities is growing their Validation team and are on the look out for highly skilled Validation Professionals
I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company is going through huge expansion at the moment and are on the lookout for Validation Specialist to join their team on a Permanent basis. This is an excellent opportunity for an individual to work closely with site teams and gain exposure and experience within a fast paced and dynamic environment.
Schedule, execute and review Cleaning Validation activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Essential Duties and Responsibilities include, but are not limited to, the following:
- Strong Quality background and familiar with Site change controls in general.
- Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports, associated data and deviations for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Schedule, execute and review Cleaning Validation activities for large and small equipment
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Collaborates with functional departments to resolve issues.
- Trains/advises less experienced Specialists.
- May supervise, provide direction and assign work to Validations Specialists to meet goals and deadlines.
- Manage and drives projects and prepare status reports.
- May present at both internal and external (regulatory) audits
- Stays current with industry trends, regulatory requirement updates, and communicating same to team
- Performs other duties assigned by Management.
Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences
- 3-5 years of related experience within the field preferred.
- Previous project management experience is highly desirable
If you would like to find out more about this role, or if you would like to be considered please click the 'apply now' button below or reach out to Kellie O' Donovan on 021 2300 300 or firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300