Description
One of my clients, a leading pharmaceutical company based in Cork, have an opening for Validation Engineer on contract basis.This is an exciting opportunity to work with one of market leaders within the Pharmaceutical industry.
Job Responsibilities:
* Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by
following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
* Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
* Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
* May also investigate and trouble-shoot problems which occur, and determine solutions.
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
* Maintains all documentation pertaining to validation.
* Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
* Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution
of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
* As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
* Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
* Coordinates assigned projects and represents department on project teams.
* May provide day-to-day guidance and training to validation technicians.
* Serves as an information resource to validation technicians, contractors and vendors.
* Resolves validation issues of moderate scope with limited direct supervision
Qualifications/Experience:
* 6 plus years of relevant experience and Degree in Science or related field.
* Extensive understanding and application of validation principles, concepts, practices, and standards.
* Proficient in current Good Manufacturing Practices (GMPs).
* Full working knowledge of equipment and systems.
* Full knowledge of industry practices.
* Strong verbal, written, and interpersonal communication skills are required.
* Investigation and report writing skills.
* Proficient in Microsoft Office applications.
Interviews will be immediate as this is a very urgent requirement. Please contact me Derek Sheridan on for more information and click apply now for immediate consideration.
To find out more about Real please visit www.realstaffing.com