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Sr. Validation Engr.
2 months ago
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.
Kelly® Science & Clinical is seeking a Senior Validation Engineer for a temporary project at a leading client in West Hills, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate:
$60-70.00/Hour (commensurate with experience)
Overview:
Our client is looking for an exceptional individual to join as a temporary Senior Validation Engineer. This position will report directly to the Manager, Quality Engineering. This is an onsite role in West Hills, CA with an approximate duration of two months.
Schedule:
Monday – Friday, 1st/Day: Standard Hours
Responsibilities:
Support company’s Quality Engineering group with documentation and validation needs.
Draft URS documents, design specifications, testing protocols, and final reports.
Perform hands on validation execution for automation implementation project.
Draft protocol discrepancy reports and support resolution.
Review and approval of validation documents.
Utilize specified company document review/approval process to submit specifications, forms, and protocols for approval.
Establish schedules with vendors and internal departments as needed.
Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
Attend Project meetings and relay project status as required.
Write/review equipment and computer system documentation – specifications, C&Q test protocols, final reports, and route for approval as required.
Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
Escalate issues to leadership as needed.
May perform project management and other tasks, as needed.
Qualifications:
Bachelor’s Degree and 5+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations.
Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle approach, and change control management.
Self-motivated/disciplined.
Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems preferred.
Strong interpersonal communications skills with excellent technical writing abilities.
Demonstrated application of engineering principles on projects.
Possess in-depth knowledge of cGMP and regulations related to biotech/pharmaceutical qualifications.
Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
Able to work collaboratively and cross-functionally with other departments and vendors.
What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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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® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
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