Validation Engineer / Medical Device

Job Title: Validation Engineer

Location: Northridge, CA

Key Responsibilities:

Develop and execute robust manufacturing validation plans and studies.

Lead the creation and execution of IQ, OQ, and PQ protocols.

Create and maintain validation documentation, including Master Validation Plans and Reports.

Perform Test Method Validation (TMV) protocol preparation and execution.

Route documents through MAP Agile (RCH/PCH) and manage follow-ups through release.

Update and maintain key documents such as Control Plans (CP), Assembly Procedures (AP), and Traveler Documents (TD).

Apply risk-based approaches and adhere to international regulatory and quality standards.

Compliance Responsibilities:

Ensure all validation activities are conducted in accordance with regulatory and quality standards.

Maintain compliance with local, national, international, and company policies for Health, Safety, and Environmental regulations.

Qualifications:

Education:

Bachelor's degree in Engineering, Science, or a related technical field.

Equivalent experience and additional certifications may be considered.

Experience:

Minimum of 3 years' experience in manufacturing validation engineering.

Background in medical device or similarly regulated industry preferred.

Strong experience in technical documentation and validation protocols.

Familiarity with PLM tools (e.g., MAP Agile) and Microsoft Office applications.

Project management and leadership experience is a plus.