MES Validation Engineer

MES Validation Engineer

Hillsboro, Oregon

** Onsite*
* Contract

Up to $89.61/hr

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* Job Title:

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* ** MES Validation Engineer*
* ** Duration: 4+ months (possible extension)*
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* Location:

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* ** Hillsboro Oregon 97124*
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* Job Summary:

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* We are seeking an experienced MES Validation Engineer to support the multi-phase deployment and validation of Manufacturing Execution Systems (MES) within a regulated manufacturing environment. This role will focus on ensuring computerized systems are validated in compliance with applicable regulatory requirements and industry standards.

The ideal candidate will collaborate cross-functionally with IT, quality, automation, and business teams to develop and execute validation strategies that support efficient and compliant manufacturing operations.
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* Key Responsibilities:

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* + Develop, draft, review, and route validation documentation including test scripts, validation protocols, and final reports for computerized systems.

+ Ensure all validation activities comply with applicable regulatory requirements and industry standards (e.g., GxP).

+ Collaborate with IT/OT, system owners, quality assurance, and business process owners to align validation strategies with existing validated systems.

+ Provide input into overall project validation strategy and risk assessments.

+ Guide overall test strategy development and ensure integration with validated environments.

+ Execute formal validation activities in a GMP-regulated environment.

+ Identify, assess, and mitigate risks associated with computerized systems.

+ Support continuous improvement of validation processes and documentation practices.

** Required Qualifications*
* + Minimum 5 years of experience as a Validation Professional in a regulated environment.

+ Proven experience developing and executing validation protocols for computerized systems.

+ Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation.

+ Solid understanding of Computerized System Validation (CSV) principles.

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Experience with Rockwell Factory Talk Pharma Suite.

+ Experience managing testing plans and execution.

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Experience with industry tools such as ERP systems, Val Genesis, LIMS, SCADA, and other regulated life sciences platforms.

+ Strong verbal and written communication skills.

+ Bachelor's degree (or equivalent experience) in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Biology, Computer Science, Technology, or related life sciences discipline.

** Preferred Qualifications*
* + Professional certifications in validation or related disciplines (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).

** You will receive the following benefits:*
* + Medical Insurance - Four medical plans to choose from for you and your family

+ Dental & Orthodontia Benefits

+ Vision Benefits

+ Health Savings Account (HSA)

+ Health and Dependent Care Flexible Spending Accounts

+ Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance

+ Hospital Indemnity Insurance

+ 401(k) including match with pre and post-tax options

+ Paid Sick Time Leave

+ Legal and Identity Protection Plans

+ Pre-tax Commuter Benefit

+ 529 College Saver Plan

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy.

Applicants need to make their needs known in advance.

** Specialization:*
* +  Technical Engineering / Design / Support