We are looking for an outstanding Validation Engineer who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver high-quality validation and supporting documentation to Manufacturing Sites and Division Engineering Projects.
This role requires strong technical, communication, interpersonal and organizational skills, and a solid understanding of the application of Regulatory, ISO standards and company policies, processes, procedures and guidelines.
The successful candidate will be able to perform, plan, schedule and estimate discipline project costs including writing, updating and reviewing of engineering studies, user requirements, validation plans, qualification protocols and reports. Generate, input, route and review items for approval in the quality system.
Duties & Responsibilities 1
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Requirements & Skills 1
Job summary 2
The Validation Engineer position is responsible for defining validation strategy and coordinating validation activities required to complete assigned validation projects in support of the operation of the Commercial Manufacturing Facility. An ideal candidate would have previous experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire.
Duties & Responsibilities 2
Requirements & Skills 2
Job summary 3
The Validation Engineer is part of a team of experienced engineers who are collaborating to ensure Company successfully delivers the latest technologies to our connected vehicles. This is a blossoming and innovative feature area that merges the latest technologies from the vehicle and cloud connectivity.
Duties & Responsibilities 3
Requirements & Skills 3
Job summary 4
As a Validation Engineer, you will serve as an experienced, individual contributor on projects and assignments that are complex in nature and that support and enhance product performance, durability, reliability, quality, and serviceability. You will plan, support, and direct machine validation activities occurring on Hydraulic Mining Shovels (HMS) working closely with our team and worldwide customer locations to support product development and continuous improvement activities.
Duties & Responsibilities 4
Requirements & Skills 4
Job summary 5
This position will provide quality support for the QC Chemistry and QC Microbiology Laboratories and will be responsible for the development and execution of protocols to support the Qualification of equipment and equipment-related systems utilized in Quality Control at Company in accordance with cGMP requirements. Technical writing skills are essential for summarizing qualification results and data for the release of equipment and systems for use within the QC Laboratories.
The Validation Engineer is responsible for understanding the current regulatory requirements and guidance, especially as it pertains to the QC Laboratory.
Duties & Responsibilities 5
Requirements & Skills 5
Job summary 6
As the Validation Engineer, you will play a critical role in supporting and expanding the company's manufacturing and quality control processes while maintaining cGMP compliance. You enjoy working in a dynamic environment with a high degree of flexibility, have experience with development and validation of automated equipment and systems in a regulated facility, and a passion to work as a leader within multi-functional teams.
Duties & Responsibilities 6
Requirements & Skills 6
Job summary 7
The Validation Engineer has ownership over product integrity as it pertains to validation of conventional & electrified automotive powertrain systems under development. Translates technical requirements & customer expectations into optimized validation plans, defines test objectives & methods, supports test execution, analyzes results, & ultimately makes technical acceptance decisions. Serves as a specialist-level technical liaison between Company and its internal & external customers.
Duties & Responsibilities 7
Requirements & Skills 7
Job summary 8
The Validation Engineer will be designated to support validations for a CGMP facility. The Validation Engineer will be responsible for assisting with executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for manufacturing equipment, clean rooms, utilities and systems using established validation templates, standards and procedures. The Validation Engineer will write and execute protocols for assigned validations. The Validation Engineer will also assist in process and cleaning validations.
Duties & Responsibilities 8
Requirements & Skills 8
Job summary 9
The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following: