Job Title: Validation Engineer
Job Description

Interface with management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met. Design and execute Validation Plans and Protocols for new and improved pharmaceutical manufacturing processes and products. Provide leadership and technical decision making for management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities. Prepare and present technical investigative reports to management as directed. Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues. Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services.

ResponsibilitiesDesign and execute Validation Plans and Protocols for new and improved pharmaceutical manufacturing processes and products.Provide leadership and technical decision making for management and high-level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.Prepare and present technical investigative reports to management as directed.Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues.Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services.Essential SkillsValidationPharmaceutical equipment validationTechnical writingDesign and execute validation plansPrepare and present technical investigative reportsSoftware validationAdditional Skills & QualificationsBS degree in an engineering or scientific discipline with a minimum of five years of experience in a pharmaceutical QA/Validation Engineering positionCertified Quality Engineer preferredDemonstrated knowledge within the areas of Industrial Quality Control, Quality Assurance, and ValidationDemonstrated knowledge in Industrial Statistics and its application to Pharmaceutical Manufacturing and Quality ControlExpertise in US FDA cGMPs as well as comparable international regulatory agency requirements for manufacturing and Quality Assurance/ControlKnowledge in software applications supporting statistical data analysis, word processing, project managementFamiliarity and understanding of manufacturing methods related to Quality Assurance/Control, and other disciplines such as engineering, chemistry, microbiology, and sterilization assuranceWork Environment

Medical device manufacturing, 100% onsite, 10 engineers on the team. You will always be working on novel situations, new challenges and projects.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/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 Mar 3, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.