Validation Engineer II

Job Title: Validation Engineer II

Location: Carlsbad, CA 92008 (On-site / In-person required for final interview)

Position Type: 06-Month Contract (Potential to extend)

Position Overview

The Validation Engineer II is responsible for creating, implementing, and maintaining the site validation program. This role ensures that all validation documentation for new and existing systems, processes, and equipment subject to design control strictly adheres to established requirements and standards within the current Quality Systems Manual. The ideal candidate will ensure that robust validation activities are implemented across all systems used to manufacture, control, and store intermediates and finished products in a highly regulated medical device environment.

Main Responsibilities

Documentation & Compliance: Write, review, and maintain validation documentation against production processes and systems in strict compliance with internal policies and external regulatory requirements.

Protocol Execution: Manage the execution of validation protocols as a Protocol Director, ensuring timely, compliant, and cost-efficient completion utilizing specialized training and technical experience.

Analysis & Reporting: Evaluate validation results from protocol executions and consult with owner/user groups to summarize findings into comprehensive final validation reports.

Lifecycle Management: Manage Validation Master Plans (VMPs) and associated reports related to new product development (NPD), as well as existing production processes, systems, and controls.

Change Control: Perform thorough validation assessments on Change Management documentation, including document, system, and process changes.

Audit Support: Represent the site during internal and external regulatory audits of validation projects and documentation.

Project Tracking: Track, monitor, and report the progress of corporate validation projects utilizing departmental project tracking tools.

Leadership & Collaboration: Provide guidance and mentorship to less experienced staff and lower-level individual contributors. May lead project teams of moderate scope and influence peers and first-level management to facilitate task completion.

Autonomy: Plan, organize, and prioritize daily work routines to meet established schedules, exercising authority and judgment within defined limits to determine appropriate actions.

Qualifications & Requirements

Education: Bachelor's degree in an Engineering, Life Sciences, or a related technical field is required. A Master's degree is highly preferred.

Experience: Minimum of 2-3 years of related work experience within a regulated industry (Medical Device, Diagnostics, or Pharmaceuticals).

Technical Knowledge: Good working technical knowledge and application of validation concepts, practices, and procedures (IQ/OQ/PQ). Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Problem Solving: Proven ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises sound judgment within defined procedures to determine appropriate action.

Quality Mindset: Experience working within a rigid Quality Management System (QMS). Understands that failure to adequately perform tasks can result in noncompliance with governmental regulations.

Interview Process

Round 1: Digital interview via Microsoft Teams.

Round 2: In-person interview at the Carlsbad, CA facility.