Validation Engineer

Overview

Coordinate and execute site validation and QA for medical device manufacturing

Key Responsibilities

• validation investigation
• equipment maintenance
• master plan
• change control
• validation protocols
• cgmp compliance

Tasks

Generation of validation investigations and implementation of corrective actions. Completing all required training before executing a task. Maintenance and tracking of validation equipment, if applicable. Generation/maintenance/execution of the Site Validation Master Plan. Management of validation, exception event, and change control processes. Documenting all activities in line with cGMP requirements. Creation/Review/Approval of various quality documents and test data. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of Project Validation Plans and schedules. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Generation of validation protocols and final reports to cGMP standards. To coordinate the development and maintenance of the site validation program and ensure client and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Performing cross training within the team and training of new team members. Updating of validation procedures, job instructions and batch documentation to reflect current best practices.

Requirements

• cgmp
• engineering degree
• validation
• multitasking
• communication
• teamwork

What You Bring

Effective interpersonal and organizational skills. Strong communication (written and oral), presentation and troubleshooting skills required Capable of prioritizing work and multitasking Ability to work well both independently and in a team environment. 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required

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About Arcadis

-Evolved into a global design, engineering and consultancy powerhouse. -Excels in major infrastructure, water management, urban building, transport and industrial manufacturing projects worldwide. -Recent standout assignments include flood defences in New York, the Sydney Metro, and sustainable legacy planning for the Paris Olympics. -Structured around core business areas—Places, Mobility, Resilience and Intelligence—backed by digital centres of excellence. -Notable for blending data-driven tools with traditional consulting to optimise asset lifecycles and smart infrastructure.

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