About Embecta
Embeca is a global diabetes care company that empowers people with diabetes to live their best life through innovative solutions and partnerships.
Career at Embecta
A career at embecta means being part of a team that values your opinions, contributions, and authentic self. You will work alongside inspirational leaders and colleagues who are passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.
Total Rewards Program
Our Total Rewards program includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components, designed to support the varying needs of our diverse and global employees.
Job Description
Senior Validation Engineer Role
The Senior Validation Engineer will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at our Dun Laoghaire site.
Responsibilities
* Be a team leader 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, 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 include day-to-day work allocation and prioritization 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 Validation Toolkits Publish site-specific progress reports as required.
* Create and control PFMEA and control plans throughout product life cycle.
* 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.
Requirements
BSc/BEng or similar relevant technical degree A minimum of 5 years high-volume engineering experience in 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.
EEO Statement
Embeca is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.