Senior Validation Engineer, P4 at Boston Scientific Corporation Malaysia

Galway, Connacht, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Engineering, Project Management, Team Leadership, Software Validation, Risk Based Qualification, Automated Systems, Database Integration, Interpersonal Skills, Continuous Improvement, Cross-Functional Collaboration, Regulatory Compliance, Creative Problem Solving, Training and Development, Mentoring, Data-Driven Insights, Equipment Validation

Industry

Medical Equipment Manufacturing

Description

Manage and mentor a team of validation engineers (staff & contractor), providing guidance, training, and career development support. Motivate and inspire individuals to achieve results while building a high-performing, engaged team culture. Provide project management, validation oversight and direction through all phases of the project lifecycle. Ensure validation deliverables meet project timelines, budgets, and scope, addressing changes proactively. Ability to assess schedule deviations and assist in the development of alternative methods for corrective action at the project level. Develop and enhance cross-functional team relationships and work collaboratively to identify and resolve issues. Level 8 Bachelor's Degree (240 credits) in a relevant engineering discipline with a minimum of 6+ years' experience in a medical device industry. 6+ years' experience in Validation Engineering, including protocol development & execution. Experience leading and developing teams, acting as a role model, and giving clear guidance and support. Demonstrated ability to manage groups with different skill levels effectively. Advanced knowledge of software validation Lifecycle Qualification & Risk based qualification strategies Proven ability to qualify and validate highly complex PC and PLC based automated systems Experience with Databases & multi-technology platform integrations is an advantage Strong project management/project lead experience with excellent interpersonal skills, PMP qualification is a distinct advantage. Ensure equipment and software validations comply with global and site standards, and applicable regulatory requirements, while maintaining up-to-date validation procedures. Ensure best validation practices are employed by the Equipment Engineering Group to maximise effectiveness and minimise non-value-add work. Works closely with customers to understand requirements and propose creative, cost-effective validation solutions. Partner with global engineering teams to share best practises and align validation strategies Travels to various BSC sites to Coordinate and oversee validation activities across multiple BSC sites as needed. Champions continuous improvement initiatives in validation processes, leveraging data-driven insights to enhance efficiencies.

Responsibilities

Manage and mentor a team of validation engineers while providing project management and validation oversight throughout the project lifecycle. Ensure validation deliverables meet project timelines and budgets, while fostering a high-performing team culture.