Process Validation

Job Title: Process Validation Engineer

Location: Maple Grove, MN

Duration: 9 Months (Onsite, 5 days/week)

A leading Medical Device company in Maple Grove, MN, is seeking a skilled Process Validation Engineer to support their Process Development teams on an urgent project. This is a critical role to ensure the successful execution of validation protocols for manufacturing processes.

Key Responsibilities:

• Execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation protocols.
• Develop, review, and approve validation documentation, including protocols and reports.
• Ensure compliance with ISO 13485 and other applicable regulatory standards.
• Collaborate with cross-functional teams, including Process Development, Quality, and Manufacturing, to support validation activities.
• Troubleshoot and resolve validation-related challenges to ensure smooth project execution.

Required Qualifications:

• Bachelor’s Degree in Engineering or a related field.
• 5 years of experience in the Medical Device industry with a focus on validation activities.
• Proven expertise in executing IQ/OQ/PQ validation protocols.
• Strong understanding of ISO 13485 standards and regulatory compliance requirements.

Bonus Experience (Preferred but not Required):

• Hands-on experience with injection molding processes.
• Familiarity with Keyence systems for inspection and measurement.