Job Description

Position: Sr Validation Engineer, Req# 16370-1

Location: Irvine, CA (100% onsite)

Duration: 9+ months contract with high possibilities of extension/conversion

Job Description:

The project will be focused on validating (IQ, OQ, PQ) of equipment. This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.

Education and Experience:

• Bachelor's degree in engineering required.
• 5-7 years of experience required.

Must-Have Requirements:

• Hands-on experience with IQ, OQ, and PQ execution
• Experience in medical device validation
• Ability to clearly explain validation concepts (IQ/OQ/PQ)
• Ability to work independently with minimal ramp-up

Nice-to-Have:

• Prior experience with the client’s Lifesciences or similar environments
• Experience as a repeat contractor in regulated environments
• Exposure to software validation within equipment systems

Soft Skills:

• Strong communication skills
• Ability to collaborate across teams
• Comfortable in fast-paced, high-priority environments
• Not siloed; team-oriented approach

Top Candidate Indicators:

• Can hit the ground running
• Requires minimal guidance
• Quickly understands project scope
• Demonstrates deep validation experience

Skills:

• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Key Responsibilities:

• Expert knowledge of Installation, Operational and Performance Qualification (IQ, OQ, PQ) of complex systems and equipment
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.

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