What are the responsibilities and job description for the Validation Engineer position at Kelly Science, Engineering, Technology & Telecom?
Contract Validation Engineer – MS Prime Implementation
Position: Contract Validation Engineer / Validation Specialist
Project Overview
Support the implementation and qualification of the bioMérieux VITEK® MS Prime system within a GMP-regulated Microbiology laboratory. This is a high-priority FDA remediation project with an aggressive implementation timeline through Q1 2027.
Primary Responsibilities
Temporary contract assignment supporting implementation, qualification, and release activities through project completion in Q1 2027-Project has potential to be extended
Priority
Immediate need to support a critical FDA remediation initiative and accelerated implementation timeline.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.
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.
Position: Contract Validation Engineer / Validation Specialist
Project Overview
Support the implementation and qualification of the bioMérieux VITEK® MS Prime system within a GMP-regulated Microbiology laboratory. This is a high-priority FDA remediation project with an aggressive implementation timeline through Q1 2027.
Primary Responsibilities
- Develop, review, and execute validation lifecycle deliverables, including requirements, specifications, risk assessments, traceability matrices, qualification protocols, and validation reports.
- Review vendor qualification and lifecycle documentation and perform gap assessments.
- Support IQ/OQ/PQ planning, execution, discrepancy resolution, and final reporting activities.
- Support change controls, deviations, impact assessments, and release-for-use activities.
- Partner with Microbiology, Quality, IT, and Vendor teams to ensure compliance and timely project execution.
- Support SOP and Work Instruction development and updates.
- Participate in project meetings, working sessions, and cross-functional planning activities.
- Identify project risks, compliance gaps, and mitigation actions.
- 5 years of Validation experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
- Experience with laboratory instrument qualification and computerized systems validation (CSV/CSA).
- Strong working knowledge of IQ/OQ/PQ, risk assessments, change control, and validation documentation.
- Experience supporting Microbiology laboratory operations and instrument implementations preferred.
- Experience with bioMérieux systems, MALDI-TOF technology, or VITEK® MS Prime is highly desirable.
- Ability to work independently in a fast-paced, project-driven environment.
- Validation document development and review
- Qualification and testing support
- Project coordination, meetings, and issue resolution
Temporary contract assignment supporting implementation, qualification, and release activities through project completion in Q1 2027-Project has potential to be extended
Priority
Immediate need to support a critical FDA remediation initiative and accelerated implementation timeline.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.
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.
Salary : $60 - $90