Validation Engineer

Jabil Malaysia; Bray; On-site; EUR 45,000 - 65,000; Full time

Job summary

Jabil Bray is seeking an experienced Validation Engineer to join our Engineering Team. You will develop and implement validation policies, review protocol data, and lead change control for critical equipment and systems.

Responsibilities include creating protocols (FAT, IQ, OQ, PQ), reviewing documentation, coordinating validation strategies, and maintaining master validation plans and procedures. The role requires regulatory knowledge (ISO 13485, 21 CFR), a quality-first mindset, and the

Qualifications

• BS in Engineering or equivalent.
• 1–3 years of validation or qualification experience in healthcare or other regulated fields.
• Experience in software validation is preferred.
• Hands-on experience with automation systems and tools used in equipment or process validation.
• Working knowledge of ISO 13485:2016 or equivalent.
• Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11 is a plus.

Responsibilities

• Develops validation and qualification protocols and tracks execution to meet project timelines.
• Develops and executes validations through FAT, IQ, SAT, OQ & PQ.
• Reviews and approves validation documentation to ensure site requirements are met.
• Coordinates and manages validation strategy for equipment and processes.
• Maintains and administers the change control program for critical equipment and systems.
• Drives continual improvement of validation programs and system-level documents.

Skills

Validation experience

Software validation

Automation systems

Regulatory knowledge

Quality systems

Education

BS in Engineering

Tools

Automation tools

Job description

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Our site in Bray is looking for the experienced Validation Engineer to join our Engineering Team.

Position Summary

Validation Engineer develops and implements validation and qualification policies, procedures and protocols. Reviews and analyses protocol data to determine if requirements are met. Prepares and submits protocol reports for internal and customer review. Champions the change control process for critical equipment and systems. Recommends corrective action where necessary and develops master validation plans.

Key Responsibilities and End Results

• Develops validation and qualification protocols and tracks execution of protocols in support of project timelines.
• Develops & executes validations through all phases i.e. FAT, IQ, SAT, OQ & PQ
• Review & Approval of validation documentation to ensure that site validation requirements are met.
• Reviews and analyses protocol data to determine if requirements are met. Resolves discrepancies and deviations during protocol execution.
• Prepares and submits validation reports for internal and customer review and approval.
• Coordinates and manages the validation and qualification strategy for equipment and processes.
• Maintains and administrates the change control program for critical equipment and systems.
• Evaluates, makes recommendations and implements improvements to the validation and qualification program as part of continual improvement activities.
• Develops and maintains validation and qualification system level documents including master validation plans, policies and procedures.
• Understanding of statistical techniques, e.g. Process Capability & Gauge RR etc.
• May be required to travel as per the requirements of the project.
• Constantly seeks to improve work processes; Has a quality-first mentality; Learns from internal and external best practices to apply to her/his work
• Supports all company Lean Manufacturing principles
• Supports all company quality programs and initiatives.
• Timeliness in addressing Quality System Requirements.
• Principles of data integrity must be strictly adhered to.
• All activities to be performed in strict accordance with the Quality Management System.
• Role model and promote the organisations Values & Behaviours.
• Must take personal accountability for your own safety.
• Support culture of safety management through compliance with all safety policies, safety observation reporting and proactive involvement in Jabil AIM and Safety First programmes.
• 100% Compliance on Monthly Safety Procedures Training. on Mont.
• Ensures compliance with all company policies and practices in areas such as safety and all regulatory compliance.
• Role model and promote the organisations Values and Behaviours.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position

Job Specifications

• BS in Engineering or Equivalent
• 1-3 years of experience in validation or qualification in healthcare or other regulated field
• Experience in software validation is preferred
• Hands-on experience with automation systems and tools used in equipment or process validation
• Working knowledge of ISO 13485:2016 or equivalent
• Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11, a plus

Accessibility Accommodation

Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [e-mail] with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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