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.
