Job Title: Validation EngineerJob Description Join our dynamic Global GQO-QA Validation team as a Staff Validation Engineer, supporting validation projects and initiatives to meet business needs. This role involves coaching and guiding multifunctional engineering teams to establish and adhere to corporate validation and process development requirements. As a high visibility and high-risk decision-making position, you will be responsible for providing technical expertise and defining best practices for local validation teams. This individual contributor role requires independent work with minimal supervision. Responsibilities + Provide interpretation and guidance on regulations and procedures related to validation activities. + Participate in the Corporate Validation Team to develop and revise validation procedures and templates, ensuring regulatory compliance and alignment with company objectives. + Engage in both Corporate and Local Validation Teams to discuss, provide feedback, and approve revisions to validation procedures. + Represent validation during internal and external audits. + Collaborate with cross-functional local and global teams, with hybrid work at manufacturing sites as required by projects. + Guide the definition of validation strategies for complex projects across multiple sites. + Ensure Validation Practitioners are trained and coached to effectively support and perform validations. + Maintain systems to evaluate changes to validated/qualified systems, ensuring their continued validated/qualified state. + Utilize quality engineering tools and statistical methods to integrate quality into new and existing products. + Implement and develop validation processes for newly acquired sites as part of mergers and acquisitions. + Work closely with product transfer, NPI, NPD, and AO teams. + Lead validation continuous improvement projects. + Implement lean and Six Sigma initiatives and lead teams in applying these methodologies. + Serve as the Subject Matter Expert for at least two validation specialties, providing primary support for these areas. Essential Skills + Bachelor of Science in Engineering or related subject with 4+ years of experience in validation GMPs. + Good understanding of engineering and machine tool fundamentals. + Efficient work methods, analytical and problem-solving skills, 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. + Knowledge/experience of risk-based techniques such as FMECAs, FTAs, RMF. + Understanding of statistical techniques, including statistical sampling plans and Process Capability. + Highly developed problem-solving and strong analytical skills. + Excellent knowledge of all validation elements and attention to detail. Additional Skills & Qualifications + Lean Six Sigma training is advantageous. + Good influencing and communication skills. + Practical and compliant approach with awareness of industry best practices. Work Environment This position is based onsite in Irvine, CA. The work environment involves collaboration with cross-functional teams and may require travel to manufacturing sites as part of the role. 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 Jul 30, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.