MES Validation Engineer
Hillsboro, Oregon
Onsite
Contract
Up to $89.61/hr
Job Title: MES Validation Engineer
Duration: 4+ months (possible extension)
Location: Hillsboro Oregon 97124
Job Summary:
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. Key Responsibilities:
Duration: 4+ months (possible extension)
Location: Hillsboro Oregon 97124
Job Summary:
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. Key Responsibilities:
- 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.
- 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.
- Experience with Rockwell FactoryTalk PharmaSuite.
- Experience managing testing plans and execution.
- Experience with industry tools such as ERP systems, ValGenesis, 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.
- 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.