English
French
Spanish
Validation Engineer
Oro Valley, AZ, US
Engineering
Contract, Contract
On-site
Other/Non Classified
Oro Valley, AZ, US
Contract, Contract
Other/Non Classified
On-site
Engineering
Job details
Title: Validation Engineer
Description: ***We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity***
***This is an on-site position that focuses on equipment validation. Pay range for this position is $39/hr-$42/hr, depending on experience***
• Experience: 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA)
• Focus: Equipment Qualification
• Employment Type: On-site position
Responsibilities
• Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems.
• Conducts risk assessments and develops qualification strategies for new and existing equipment/systems.
• Analyzes and interprets qualification data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety Health and Environment (SHE), to ensure seamless execution of qualification activities and successful achievement of qualification-related project milestones.
• Participates in process optimization and continuous improvement initiatives to enhance quality and efficiency.
• Ensures compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
• Provides training and guidance to manufacturing and quality personnel on qualification processes and procedures.
• Maintains equipment/systems qualification documentation and ensures traceability and accessibility for audits and inspections.
• Other duties as assigned by management.
Qualifications
• Bachelor’s Degree in Engineering or Life Science.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Demonstrated experience assisting with or supporting qualification activities within the medical device, pharmaceutical, or biotechnology industry is required.
Skills:
I want more jobs like this in my inbox.
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.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.