Validation Engineer

Job Title: Validation EngineerJob Description

As a member of the Global GQO-QA Validation team, the Staff Validation Engineer will support validation projects and initiatives according to business needs. This role involves coaching and guiding multifunctional engineering teams to effectively establish and meet validation and process development corporate requirements. You will be responsible for local validation teams in terms of technical expertise and definition of best practices. This position holds high visibility and involves high-risk decision-making. As an individual contributor, you will use your judgment in applying professional expertise and are expected to work independently with minimal supervision.

Responsibilities

Provide interpretation and guidance on regulations, corporate, divisional, and site local procedures related to validation activities.

Participate in the Corporate Validation Team to develop and revise validation procedures and templates, ensuring compliance with current regulatory standards and company objectives.

Participate in corporate and local validation teams to discuss, provide 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 as required, on a hybrid basis.

Guide the definition of validation strategies for highly complex validation projects across multiple sites.

Ensure that validation practitioners receive training and coaching to effectively support and perform validations for current and anticipated projects.

Ensure appropriate systems are in place to evaluate changes to validated/qualified systems, maintaining their validated/qualified state.

Utilize quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to incorporate quality into new and existing products.

Implement and develop the validation process for newly acquired sites as part of mergers and acquisitions teams.

Work closely with product transfer, NPI, NPD, and AO teams.

Lead validation continuous improvement projects.

Implement lean and Six Sigma initiatives and lead teams to apply these methodologies.

Act as the Subject Matter Expert responsible for at least two validation specialties and provide primary support for those specialties, such as Computer System Validation (CSV) or Qualification of Buildings, Facilities and Utilities (BFU).

Essential Skills

Bachelor of Science in Engineering or a related subject with 4+ years of experience in validation GMPs.

Good understanding of engineering and machine tool fundamentals.

Self-starter with efficient work methods, analytical and problem-solving skills, and the 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, particularly statistical sampling plans, process capability, and R&Rs.

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 & Qualifications

Lean Six Sigma training is a distinct advantage.

Work Environment

The position is onsite in Irvine, CA. Employees can expect a professional environment that fosters collaboration and innovation.

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 1, 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 (%) for other accommodation options.