Description
I have an immediate opening for Senior Validation Engineer with a leading medical device company in Co Clare. This is a 12 month fixed term contract position to assist the company on a major project.Main Responsibilities:
* Develop and maintain site master validation plan and process procedures and templates in line with corporate and regulatory requirements for validation of processes, equipment. utilities
* Support computer systems validation elements of site project schedules together with the IT Manager
* Plan and develop annual site validation project schedule with different business centre managers and ensure project objectives and resources are agreed, and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritization of validation activities in line with the project schedules and plant priorities.
* Lead, integrate & project manage validation tasks and develop strategies on all validation projects with multifunctional project teams ensuring project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.
* Provide guidance and support to all departments to ensure they understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures and guidelines
* Prepare, review and execute site validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/standards
* Participate in the preparation of user requirement specifications to ensure that they comply with Validation and GMP requirements as required
* Execute/co-ordinate re-validation/qualification activities as required
* Direct and support activities of validation engineers and provide development feedback and opportunities to assist in their daily activities.
* Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements
* Represent validation at both internal and external audits.
* Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents
* Provide technical expertise during investigations, gap analysis, risk assessment and change control process.
* Support the DBS improvement initiatives
* Co-ordinate/supervise contractor activities as required.
* Administer validation files and ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
* Organize / provide validation related training for site personnel as appropriate
Qualifications
Third level degree in science or engineering in addition to a minimum of three years validation experience in a GMP/FDA/IMB regulated environment in addition to experience of formal regulatory audits (e.g. FDA/IMB). Good working knowledge of statistics.
If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.