Talent.com
Validation Engineer
Validation EngineerKatalyst HealthCares & Life Sciences • Irvine, CA
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life Sciences • Irvine, CA
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Description :

The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives.

Responsibilities :

  • Interpret and implement validation requirements based on FDA regulations, corporate standards, and site-specific procedures.
  • Represent validation activities during internal and external audits.
  • Participate in corporate validation teams to review and update global procedures and templates.
  • Lead the definition and execution of validation strategies across high-complexity projects.
  • Support and coach validation engineers and cross-functional teams in process development and validation best practices.
  • Develop and maintain systems to control changes to validated equipment or systems.
  • Drive validation efforts during mergers and acquisitions, ensuring alignment with corporate requirements.
  • Collaborate with teams involved in NPI, NPD, product transfer, and automation.
  • Champion and lead Lean / Six Sigma initiatives and continuous improvement projects.
  • Maintain expertise in at least two core validation disciplines (, CSV, BFU Qualification).

Requirements :

  • Bachelor's degree in engineering or a related field.
  • years of hands-on validation experience in a GMP-regulated medical device environment.
  • Strong knowledge of IQ / OQ / PQ protocols.
  • Direct FDA audit experience, with the ability to represent validation activities.
  • Expertise in Risk-Based Techniques (FMEA, FTA, Risk Management Framework).
  • Familiarity with statistical methods : sampling plans, R&R studies, process capability.
  • Demonstrated ability to write and own validation protocols and reports.
  • Strong analytical, problem-solving, and documentation skills.
  • Experience implementing Lean and Six Sigma tools (certification preferred).
  • Excellent written and verbal communication skills.
  • Comfortable working independently and in cross-functional teams.
    • serp_jobs.job_alerts.create_a_job

    Validation Engineer • Irvine, CA

    Job_description.internal_linking.related_jobs
    Senior Validation Engineer

    Senior Validation Engineer

    PSC Biotech • Pomona, California, USA
    serp_jobs.job_card.full_time
    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applica...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    ASIC VLSI Synthesis and Design Engineer

    ASIC VLSI Synthesis and Design Engineer

    Mice Groups • Irvine, CA, US
    serp_jobs.job_card.permanent
    Senior ASIC VLSI Synthesis and Design Engineer / Direct Hire, FTE / Onsite in Irvine, CA or Santa Clara, CA / Candidates must be US Citizens or Green Card holders / Salary range $185-225K Our clien...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Customer Service Representative

    Customer Service Representative

    Chevron • Dana Point, CA, US
    serp_jobs.job_card.full_time +1
    At Chevron Stations Inc (CSI), we sell gasoline and convenience products at our retail stations.We are looking for hard working people who value safety, enjoy working as a team and have a positive ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Sr. Validation Engineer II

    Sr. Validation Engineer II

    Gilead Sciences • La Verne, California, USA
    serp_jobs.job_card.full_time
    At Gilead were creating a healthier world for all people.For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Validation Engineering Intern

    Validation Engineering Intern

    B Braun Medical • Irvine, CA, United States
    serp_jobs.job_card.full_time
    You're an important part of our future.Hopefully, we're also a part of your future! At B.Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Digital Transformation Engineer

    Digital Transformation Engineer

    Howmet • Rancho Cucamonga, CA, United States
    serp_jobs.job_card.full_time
    Arrow Route, Rancho Cucamonga, CA, 91730, US.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfully obtain access to s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Site Reliability Engineer

    Site Reliability Engineer

    Varnish Software • Irvine, California, United States
    serp_jobs.job_card.full_time
    At Varnish Software, we empower the world’s largest content providers to deliver lightning-fast web and streaming experiences, ensuring resilience and scalability for massive audiences.Our open-sou...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Research And Development Engineer

    Research And Development Engineer

    I3 INFOTEK INC • Irvine, CA, US
    serp_jobs.job_card.full_time
    The R&D Engineer will support product development activities within the medical device domain, contributing to the design, documentation, and improvement of products in accordance with regulato...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Engineering

    Engineering

    Confidential • Irvine, CA, United States
    serp_jobs.job_card.full_time
    Samsung Research America has the following openings in Irvine, • • • • • Engineer, Machine • • • • • Write efficient implementations of ML algrhtms over CPUs & GPUs, deploy production environment.MS or...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Security Engineer

    Security Engineer

    TEKsystems • Irvine, CA, United States
    serp_jobs.job_card.full_time
    BEC (Business Email Compromise).SentinelOne administration : Deploy, configure, and maintain SentinelOne EDR across enterprise endpoints. Threat detection and response : Monitor alerts, investigate su...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    SUPERVISORY DISTINGUISHED ENGINEER OR SCIENTIST

    SUPERVISORY DISTINGUISHED ENGINEER OR SCIENTIST

    Naval Sea Systems Command • Corona, CA, US
    serp_jobs.job_card.temporary
    You will oversee the technical direction of the research, development, test, and evaluation (RDT and E) programs conducted to support Corona Division mission to include assessment of surface ship w...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Data Annotation • San Clemente, California
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Site Reliability Engineer (AKS)

    Site Reliability Engineer (AKS)

    Ascending • Irvine, California, United States
    serp_jobs.job_card.full_time
    Senior Site Reliability Engineer.Our client, a premier national healthcare provider, is currently looking for a Senior Site Reliability Engineer on their Cloud Infrastructure team.You will be helpi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    AI Engineer

    AI Engineer

    Sales Hub Careers • Chino Hills, California, United States
    serp_jobs.job_card.full_time
    Sales-Hub is a fully customizable sales software for business.We believe in delivering intelligent products you can rely on, making our software the perfect tool to run and accelerate your business...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    AI Platform Engineer IV

    AI Platform Engineer IV

    Capital Group • Irvine, CA, United States
    serp_jobs.job_card.full_time
    I can succeed as an AI Platform Engineer at Capital Group.As an AI Platform Engineer, you will design, build, and operate the foundational components of Capital Group's enterprise AI platform, enab...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Analog and Mixed Signal Bench Testing Engineer Contractor

    Analog and Mixed Signal Bench Testing Engineer Contractor

    OSI Engineering • Irvine, CA, US
    serp_jobs.job_card.full_time
    Analog and Mixed Signal Bench Testing Engineer Contractor Overview This position involves bench testing the analog and mixed-signal portion of our IC product(s). The candidate will be responsible fo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Remote CUDA Kernel Optimizer - ML Engineer - AI Trainer ($120-$250 per hour)

    Remote CUDA Kernel Optimizer - ML Engineer - AI Trainer ($120-$250 per hour)

    Mercor • San Clemente, California, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Role Overview • • Mercor is engaging advanced CUDA experts who specialize in GPU kernel optimization, performance profiling, and numerical efficiency. These professionals possess a deep mental model o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Analytics Engineer

    Analytics Engineer

    Anduril • Irvine, California, United States
    serp_jobs.job_card.full_time +1
    We build robots that find other robots and knock them out of the sky.At a time when air superiority can no longer be taken for granted, the Air Defense (AD) Team provides mission critical capabilit...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted