Director of Validation Job Listing at Kelly Services in Sacramento, CA (Job ID 10129723)

Description

Director of Validation
Sacramento, CA
Onsite
Target Salary: $160,000

Kelly Engineering is seeking a Director of Validation for a sterile pharmaceutical manufacturing facility in Sacramento, CA.

This leadership role is responsible for overseeing and advancing all validation activities across a commercial sterile manufacturing site. The Director of Validation ensures that facilities, utilities, equipment, processes, cleaning systems, and computerized systems remain in a validated state in full compliance with FDA and global regulatory requirements.

Key Responsibilities

• Lead and execute the site Validation Master Plan
• Oversee validation for aseptic processing and fill/finish operations
• Direct cleanroom and controlled environment validation
• Manage utilities validation including WFI, clean steam, HVAC, and compressed gases
• Oversee equipment qualification including autoclaves, washers, filling lines, isolators, and RABs
• Lead process validation including PPQ and continued process verification
• Direct cleaning validation and computerized systems validation
• Serve as validation subject matter expert during regulatory inspections
• Partner cross-functionally with Quality, Engineering, Manufacturing, Automation, IT, and Regulatory Affairs
• Lead and develop a team of validation engineers and managers
• Drive risk-based validation and continuous improvement initiatives

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field
• 10+ years of validation experience within GMP pharmaceutical manufacturing
• Minimum 5 years of leadership experience in sterile or aseptic environments
• Strong knowledge of FDA, EMA, ICH, and Annex 1 requirements
• Experience supporting FDA inspections and commercial manufacturing operations
• Deep expertise in lifecycle validation and risk-based approaches

Additional Requirements

• Must live within or be willing to relocate to the Sacramento Metropolitan region
• Onsite presence required to support sterile manufacturing operations
• This is an opportunity to lead validation strategy at a growing commercial sterile facility while ensuring regulatory compliance, patient safety, and operational excellence.

If you have a strong background in sterile validation leadership and are ready to drive impact at a site level, we encourage you to apply.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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