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embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and  Twitter .

This role will lead the validation team, managing the validation and Advanced Product Quality Planning lifecycle for the Dun Laoghaire site, including design transfer and the technical aspect of the validation lifecycle to drive continuous improvement activities.

Responsibilities:

• Act as lead within the validation team for all technical and equipment validation projects in line with predetermined protocols and production requirements.

• Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.

• Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development and DOE activities

• Produce and maintain appropriate and comprehensive validation policy and procedures.

• Ensure execution of allocated validations according to the plant Validation Master Plan.

• Provide input, monitor and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.

• Write and implement validation system documentation as required.

• Ensure the Review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures

• Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently

• As a member of the Quality group, to liaise with Operations, planning and Engineering groups to ensure successful validation of all manufacturing processes.

• Plant SME for Process Validation Execution

• Manage the activities of a defined team of Validation Engineers. Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties

• Draft and Approve protocols and reports as required.

• Execution of IQ, Process Development, OQ and PQ on new/revised processes as required

• Local use of (BD and Unit level) Validation Toolkits

• Publish site specific progress reports as required.

• Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]

• Create and control PFMEA and control plans throughout product life cycle.

• Assist with Process Development, conduct DOE and MSA.

• Participate in regulatory audits and inspections.

• To link with Post Validation activities including closure of ACR and ECO (Change Control).

• Support site change control procedures

• Any other reasonable duties which may be required by management

Education and Experience

• A minimum of 5 years high volume engineering experience in a Medical Devices.

• A minimum of 3 years validation experience

• Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes

• Process development experience (DOE’s etc)

• Risk Analysis/Risk Management, FMEA’s, etc.

• Strong documentation skills

• Ability to work on own initiative and as part of a team.

• Strong interpersonal and communication skills.

• Process validation training and experience

• Strong technical and problem-solving skills.