BD (Becton, Dickinson and Company) Senior/ Quality Engineer - Validation in Tuas, Singapore
Job Description Summary
The Quality Engineer - Validation reports to the Quality Manager for the responsible and accountable of establishing and coordinating all the validation activities for materials, products, equipment, processes and software. Maintaining the Validation Master Plan and training associates engaged in validation activities.
The Quality Engineer - Validation is responsible leading the Risk Analysis/ PFMEA to identify needs for validation of manufacturing equipment/ process/ software and support systems to meet product requirements, regulations, quality and company policies.
Responsible for developing, implementing and maintaining the Risk Analysis/ FMEA and Validation Master Plan for the Plant.
Manage the Validation Tracking Schedule to ensure compliance with validation completion timelines and ensure its currency and accuracy.
Perform and/or coordinate with Validation Practitioners the development of required validation protocols and the execution of the validation.
Coordinate, supervise groups of Validation Practitioner, Contributors, Engineers and/or technicians on an ongoing validation activity for any projects.
Prepare, review and approve the validation reports for completion, as well as close-outs of validations, following Validation Tool Kit practices.
Responsible for providing support, training and assistance to on-site Validation Practitioners and contributors.
Responsible for ensuring Validation Contractors compliance to BD Validation Policy and Procedures. Develop project scopes, schedules and budgets.
Continuously evaluate information related to the overall performance of manufacturing process/ equipment/ software and any relevant support systems in addition to field complaints to activate re-validation activities when required.
Create, revise or update validation procedures and policies as required. Prepare Change Notification documentation as required for procedures or processes as a result of validation requirements.
Responsible of the quarantine the further processing of product in the event a non-conformance is detected during validation process.
Work with US Sites validation teams to sustain validation activities.
Participate in Management Reviews and Executive Steering Committee to report on Validation Status as assigned.
Assists in Internal QA Auditing Program, external regulatory and compliance audits/ inspections as required.
Participates and contributes to continuous improvement activities. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements, brings regulatory compliance questions/ issues to the attention of management and/ or provide recommendations to improve effectiveness of validation work.
Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally-friendly workplace by observing Company’s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
Safety & health accountability:Safety and health are important to BD and we encourage the observance of all safety programs and training assigned to you. Such programs are to be attended in a timely manner to ensure that work tasks carried out are in accordance to our safety guidelines and SOPs.
Performs other duties as requested by Facilitator.
Primary Work Location
SGP Tuas - Tuas Plant
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.