🌟 Job Opening: Staff Validation Engineer

Location: Irvine, CA

Department: Global GQO-QA Validation Team

Job Type: Full-Time | Onsite with Hybrid Work as Needed

📌 About the Role

As a Staff Validation Engineer, you'll play a pivotal role in driving validation excellence across global initiatives. You'll guide across-functional engineering teams through complex validation and process development projects while ensuring alignment with corporate requirements and regulatory compliance. This high-visibility, high-impact role demands technical precision, strategic leadership, and autonomy.

🛠️ Key Responsibilities

Provide expert interpretation of industry regulations and corporate procedures related to validation.Partner with Corporate Validation to develop, revise, and maintain validation policies and templates.Collaborate with local and global validation teams to approve procedural updates.Represent validation during internal audits and regulatory inspections.Lead cross-site validation projects; travel to manufacturing sites as required.Define and implement validation strategies for complex, multi-site programs.Coach and mentor engineering teams to build validation capabilities.Establish systems for maintaining validated states of critical systems after changes.Apply engineering tools and statistical methods to integrate quality into products and processes.Spearhead validation for newly acquired sites as part of merger & acquisition teams.Support NPI, NPD, AO, and product transfer activities.Drive continuous improvement initiatives through lean and Six Sigma methodologies.Serve as the subject matter expert in at least two validation specialties.

🧠 Qualifications

Bachelor’s degree in Engineering, Science, or a related field.Minimum 4+ years of GMP validation experience.Solid grasp of engineering fundamentals and machine tooling.Proactive, analytical thinker with excellent multitasking abilities.Comfortable working in fast-paced, multi-site environments with travel flexibility.Proficient in risk-based validation techniques (e.g., FMECA, FTA, RMF).Strong statistical knowledge including sampling plans and process capability.Detail-oriented with top-tier problem-solving and communication skills.Influential collaborator with a compliance-first mindset.

🎯 Preferred Skills

Formal training in Lean Six Sigma methodologies.Experience leading validation projects through acquisition transitions.Strong understanding of validation elements within a regulated manufacturing context.

🌱 Work Environment & Perks

Based in our Irvine, CA facility, this position offers:

A dynamic work environment in a leading medical device organizationTwo weeks paid vacation plus additional PTOOpportunities for growth in Validation and QA

Pay and Benefits

The pay range for this position is $60.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Aug 12, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.