Sr Quality Engineer

Senior Quality Engineer – Validation Focus (Pharma / Combination Products)

Location: Petaluma, CA (100% Onsite)

Employment Type: Contract-to-Hire

Pay Rate: $65–$75/hr (based on relevant experience)

About The Opportunity

Kelly Engineering is supporting a rapidly growing biotech company developing next-generation anti-infective technologies to address antibiotic-resistant pathogens.

This organization is in a critical phase of growth and commercialization, offering the opportunity to make a direct impact in a fast-paced, innovative environment.

Position Overview

We are seeking a Senior Quality Engineer with strong validation expertise to support product development, manufacturing scale-up, and commercialization readiness.

This is a highly hands-on role focused on execution. The ideal candidate will bring deep experience in validation and a strong engineering mindset, and will be comfortable working in a fast-moving, evolving environment.

Key Responsibilities

Validation & Technical Execution

• Lead and execute process, equipment, cleaning, and computer system validations (CSV)
• Author and execute IQ/OQ/PQ protocols, validation reports, and supporting documentation
• Ensure compliance with GMP and FDA regulations
  
  

Quality Systems & Compliance

• Support deviations, investigations, root cause analysis, and CAPAs
• Assist with change control activities related to manufacturing processes and systems
• Develop and maintain SOPs and quality documentation
  
  

Cross-Functional Collaboration

• Partner with Engineering, Manufacturing, R&D, and Regulatory teams
• Support scale-up, tech transfer, and commercialization efforts
• Provide quality input on technical and process decisions
  
  

Audit & Inspection Readiness

• Support internal audits and regulatory inspections
• Ensure validation documentation and quality records are inspection-ready
  
  

Qualifications

Required

• 6–10 years of experience in a GMP-regulated environment (pharma, biotech, or combination products)
• Strong hands-on experience with validation (IQ/OQ/PQ execution required)
• Proven experience writing and executing validation protocols and reports
• Solid understanding of manufacturing processes and equipment validation
• Ability to work onsite in Petaluma, CA
  
  

Preferred

• Bachelor’s degree in Engineering or related technical field
• Experience with combination products or medical devices
• Exposure to Computer System Validation (CSV)
• Familiarity with statistical methods for validation (sampling, process capability, etc.)
  
  

Work Environment

This is a fast-paced, startup-like environment where processes are still evolving. The ideal candidate is:

• Comfortable working in less structured settings
• Hands-on and proactive
• Able to adapt quickly and solve problems independently
  
  

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.