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Validation Specialist

Kelly Services

Houston, TX
Job Code:
Kelly Services
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Job Details

Job Title Validation Specialist

Jobid US589HHM_BH1433668

Location: Houston, TX, 77007, USA

Description Kelly Scientific Resources is currently seeking a Validation Scientist for a leading biotechnology company in the Houston, TX area. This is a direct hire, permanent opportunity!

As a Validation Specialist placed with Kelly Scientific Resources, you will be working on process validation activities for vaccine production. This role will require specific expertise and knowledge of biological production processes such as cell culture, fermentation, and purification.


+ Independently review and approve process validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.
+ Provide independent QA input to process validation projects in support of commercial biomanufacturing in an aseptic or sterile manufacturing environment.
+ Provide direction to project teams on compliance/technical issues related to process validation efforts to achieve compliance with company policies and government regulations.
+ Review validation documentation for compliance with company policies and government regulations.
+ Approve documents for specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.
+ Review and approve all computer validation documentation such as User Requirement Specifications, Functional Requirement Specifications, Initial Qualification, Operational Qualification, Performance Qualification, and Validation Summary Reports.

+ Minimum Bachelor degree in scientific discipline
+ At least 3 years of experience with a biomanufacturing process Validation & Compliance/QA background
+ Industry experience specifically from biotech/biologics/vaccine production environment
+ Previous laboratory experience with cell culture, fermentation, and/or purification of protein-based products
+ Previous experience with process design for biomanufacturing facilities and equipment validation.
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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