Validation Engineer

Plymouth, MN

Instant Apply

30+ days ago

Job Description

Job Summary:
We are seeking an experienced Validation Engineer to support validation activities, quality systems, process improvements, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience developing and executing validation protocols, working with FDA and ISO requirements, conducting root cause analysis, and supporting quality and compliance initiatives.

Roles and Responsibilities:

Develop, review, and execute IQ/OQ/PQ validation protocols and reports for manufacturing processes, equipment, and software.
Support process validation, equipment qualification, and verification & validation (V&V) activities.
Review validation documentation and identify compliance gaps or deviations.
Support investigation and resolution of validation-related issues, including CAPA and corrective actions.
Perform root cause analysis (RCA) and support implementation of effective corrective and preventive actions.
Support FDA inspection readiness and ongoing quality system activities.
Ensure validation activities comply with applicable FDA regulations and ISO standards.
Participate in process improvement and continuous improvement initiatives.
Apply statistical methods and data analysis to evaluate process performance and validation results.
Use tools such as Minitab for statistical analysis, including interpretation of P-values and other statistical measures.
Prepare and maintain validation protocols, reports, risk assessments, and supporting documentation.
Collaborate with Quality, Engineering, Manufacturing, R&D, and other cross-functional teams to manage validation projects.
Work directly with customers and internal stakeholders to understand validation requirements and project expectations.
Support new product development activities and ensure appropriate validation requirements are incorporated.
Maintain accurate and compliant validation records in accordance with company procedures and regulatory requirements.

Education & Experience:

Bachelor's degree in engineering, Science, or a related technical discipline.
Degrees in areas such as Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or Life Sciences are preferred.
3–5 years of validation experience in a regulated industry, preferably medical devices, pharmaceuticals, biotechnology, or other highly regulated manufacturing environments.
Hands-on experience with IQ/OQ/PQ and process/equipment validation.

Numbers & Facts

Location

Plymouth, MN

Skills

Biotech and Pharmaceuticalunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Documentationunmatched
Equipment Validationunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Minitabunmatched
Process Improvementunmatched
Process Validationunmatched
Product Developmentunmatched
Product Supportunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Regulatory Requirementsunmatched
Requirements Validation/Verificationunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
Statisticsunmatched
Team Lead/Managerunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched

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