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Senior Validation Engineer
1 month ago
Hillsboro, United States Naderi Engineering, Inc. Full timeM-F and weekend on-call supportMain Purpose of the Position:The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).Responsibilities:Develop and manage the detailed project plans...
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Senior Validation Engineer
4 weeks ago
Hillsboro, United States TalentBurst, an Inc 5000 company Full timeTitle: Sr Validation Engineer, Req#: ROCGJP00027216 Location: Hillsboro, OR (100% onsite) Duration: 4+ months Contract (with the possibility of extension based on performance)Schedule: Monday - Friday and weekend on-call supportJob Description:The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and...
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Senior Validation Engineer
4 weeks ago
Hillsboro, United States TalentBurst, an Inc 5000 company Full timeTitle: Sr Validation Engineer, Req#: ROCGJP00027216 Location: Hillsboro, OR (100% onsite) Duration: 4+ months Contract (with the possibility of extension based on performance)Schedule: Monday - Friday and weekend on-call supportJob Description:The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and...
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Senior Validation Engineer
4 weeks ago
Hillsboro, United States TalentBurst, an Inc 5000 company Full timeTitle: Sr Validation Engineer, Req#: ROCGJP00027216Location: Hillsboro, OR (100% onsite)Duration: 4+ months Contract (with the possibility of extension based on performance)Schedule: Monday - Friday and weekend on-call supportJob Description:The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and...
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Sr. Validation Engineer
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Hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full timeBEPC is looking for a Sr. Validation Engineer in Hillsboro, OR to join our fast-growing team of consultants!W2 Contract: 3 months with opportunities for extensions based on business needs and performance.Pay Range: $64.77-68.77/hr. plus we offer Medical, Dental, Vision and Life Insurance benefits!Schedule: 100% Onsite, M-F and weekend on-call support.Main...
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Hillsboro, United States Genentech Full timePosition OverviewAs a Quality Validation Engineer II/Senior at Genentech, you will leverage your expertise in qualification and validation methodologies to ensure the highest standards of quality in our manufacturing processes.Key ResponsibilitiesUtilize your knowledge of quality systems and engineering design principles to assess and enhance product...
Senior Validation Engineer
1 month ago
Sr Validation Engineer
Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124
Main Purpose of the Position:
The Senior Validation Engineer will be responsible for performing various validation activities, including Commissioning and Qualification, Performance Qualification (PQ), Cleaning Validation (CV), Process Validation (PV), and Revalidation (RV). This role requires managing detailed project plans, preparing validation documentation, leading execution activities, and ensuring systems are implemented within predetermined timelines and financial forecasts.
Responsibilities:
- Develop and manage detailed project plans and timelines for validation activities.
- Prepare validation and change control documentation, including protocols and summary reports.
- Lead the execution of CD/PQ/CV/PV/RV activities.
- Act as project manager for validation deliverables, ensuring adherence to timelines and budget.
- Track and report issues impacting predetermined timelines.
- Provide input into investigations with potential validation impact.
- Coordinate sample collection, testing, analysis, and reporting per validation protocol.
- Support the change management system for validated equipment, utilities, and facilities.
- Assist in the development of manufacturing documents as appropriate.
Qualifications / Requirements:
- BS/MS in Chemical, Biochemical Engineering, or related field/experience.
- Minimum of 8 years (BS) or 6 years (MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services.
- Experience in the pharma/biotech industry, specifically with cleaning and sterilization validation.
- Demonstrated understanding of cleaning and sterilization qualification requirements in a cGMP environment.
- Proven project management skills.
- Experience in authoring, reviewing, and executing validation protocols.
- Knowledge of cGMPs or equivalent regulations.
- Familiarity with formulation, filling, packaging, and equipment qualification in a regulated environment.
- Ability to collaborate with internal teams, partners, suppliers, and customers.
- Operational excellence and industrial engineering skills are a plus.
- Professional level written and oral communication skills.