Validation Engineer 2

Illumina • San Diego, CA

4d

About The Position

The validation engineer 2 works as an integral part of the validation team supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining. Collaborate in a dynamic team-oriented environment and lead the effort for defining, implementing and maintaining validation for manufacturing processes and systems. Become highly proficient in use of Validation Life Cycle Management System.

Requirements

• Minimum Requirements
• Bachelor's Degree STEM field
• 2-5 years System/process validation or process engineering

Nice To Haves

• Preferred Qualifications
• Experience in the medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
• Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis
• Knowledge and working application of Quality Management Systems
• Demonstrated strong analytical problem solving , team and communications/interpersonal skills
• Computer competency in MS Office
• Excellent written, technical and verbal communication skills
• Adaptable to fast-paced, dynamic work environment with ability methodically manage projects

Responsibilities

• Develops and articulates robust strategies for validation of processes/systems and generate validation plans
• Develops validation protocols for and oversee execution of IQ, OQ, PQ and manufacturing processes, systems and equipment in collaboration with end users and process owners
• Writes reports summarizing validation study results and statistics for manufacturing process, systems and software validation projects
• Writes and executes manual tests for software and system validation
• Analyzes and documents test results and generate validation reports
• May operate a variety of laboratory instrumentation and simulators to perform integration testing, system testing, and functionality testing with new software
• May assist software developers and domain experts in designing, performing, and improving verification tests
• Provides input for creation of requirements documents
• Learns, understands, and applies technologies pertinent to systems, processes and products; engage in technical discussions as required
• Participates in creation of risk management documents such as FMEA for systems and processes
• Ensures validation program meets requirements of FDA (21 CFR Part 11) and applicable international standards (e.g. ISO-13485)
• Collaborates with cross-disciplinary project teams to meet project milestones and end goals
• Provides consultation to other departments performing validation activities
• May lead cross-functional teams to address software and system level issues
• Initiates, updates, and/or approves controlled document change requests
• Performs other related tasks assigned by the supervisor

Benefits

• We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
• We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission.
• Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.
• We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race.
• We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level