Senior Validation Engineer - Ireland - Asset Recruitment

Description

ref. 01171

Senior Validation Engineer

Leading healthcare safety and technologies for more than a century, our client is a well-known high volume manufacturing company in South Dublin, currently seeking an individual enthusiastic about contributing with the company's vision and work culture in a key role as a Senior Validation Engineer.

Summary

Reporting to the Senior Quality Manager this role consists of overseeing the validation team's operations, directing the validation and Advanced Product Quality Planning life cycle at the Dun Laoghaire site. Manage design transfers and the technical aspects of validation procedures to promote continuous improvement.

Primarily responsibilities

– Take charge of technical and equipment validation projects within the validation team, ensuring adherence to predefined protocols and production prerequisites.
– Validate the design, installation, and operation of Plant and Equipment in compliance with prevailing regulatory standards.
– Execute allocated validations as per the plant's Validation Master Plan.
– Collaborate with relevant primary teams to oversee the content of the Validation Master Plan, ensuring compliance through regular management reviews.
– Draft and implement necessary validation system documentation.
– Review and endorse validation lifecycle documentation, ensuring alignment with company standards and protocols.
– Engage with Operations, Planning, and Engineering groups as a Quality team member to ensure successful validation of manufacturing processes.
– Act as the Plant Subject Matter Expert for Process Validation Execution.
– Manage a designated team of Validation Engineers, overseeing work allocation, quality reviews, coaching, training, and general personnel support.
– Prepare and approve required protocols and reports, executing IQ, Process Development, OQ, and PQ on new/revised processes.
– Ensure the quality of completed validations (Effectiveness, schedule adherence, minimum deviations).
– Develop and control PFMEA and control plans throughout the product life cycle.
– Support Process Development, conduct DOE and MSA, participate in regulatory audits and inspections, and contribute to post-validation activities.
– Assist in closure of ACR and ECO (Change Control) and support site change control procedures.
– Fulfil any other reasonable duties as required by management.

Requirements

– A degree in Mechanical, Electrical, or a related Engineering field.
– 5 years + of high-volume engineering experience in Medical Devices.
– 3 years + of validation experience.
– Proficiency in statistical techniques, Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes.
– Expertise in process development including DOE, Risk Analysis/Risk Management, FMEA's, etc.
– Strong documentation, problem-solving, interpersonal, and communication skills.
– Training and experience in process validation.