Job Description
As a Staff Validation Engineer within the Global GQO-QA Validation team, you will support validation projects and initiatives according to business needs. You will coach and guide multifunctional engineering teams to effectively establish and meet the validation and process development corporate requirements. This role involves high visibility and high-risk decision-making and requires working independently with minimal supervision.
ResponsibilitiesProvide interpretation and guidance on regulations, corporate, divisional, and site local procedures as they relate to validation activities.Participate within the Corporate Validation Team to develop and revise validation procedures and templates to ensure current regulatory compliance and company objectives are maintained.Contribute to both corporate and local validation teams to discuss, give feedback, and approve revisions to validation procedures.Represent validation at both internal and external audits.Work as part of several cross-functional local and global teams; visit and work on manufacturing sites per project requirements on a hybrid basis.Guide the definition of validation strategies for highly complex validation projects (multiple sites).Ensure validation practitioners receive training/coaching to effectively support and/or perform validations for current and anticipated projects.Ensure appropriate systems are in place to evaluate changes to validated/qualified systems to ensure their continued validated/qualified state.Utilize quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to build quality into new and existing products.Implement and develop the validation process for newly acquired sites as part of the merge and acquisitions teams.Work closely with product transfer, NPI, NPD, and AO teams.Lead validation continuous improvement projects.Implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies.Act as the subject matter expert responsible for at least two validation specialties and be the primary support for those specialties.Essential SkillsBachelor of Science, Engineering, or related subject with 4+ years of experience in validation GMPs.Good understanding of engineering and machine tool fundamentals.Self-starter with demonstrated efficient work methods, analytical and problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.Willingness to work as part of a multi-site team and ability to travel as part of the job.Working knowledge/experience of risk-based techniques, i.e., FMECAs, FTAs, RMF, etc.Understanding of statistical techniques, particularly statistical sampling plans and process capability.Highly developed problem-solving and strong analytical skills.Excellent knowledge of all validation elements and attention to detail.Good influencing and communication skills, with a practical and compliant approach.Additional Skills & QualificationsLean Six Sigma training is a distinct advantage.Work Environment
The work environment is onsite in Irvine, CA. Employees enjoy benefits such as two weeks PTO and additional paid time off in Medical Device 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 15, 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.