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20 days old

Biopharma Validation Specialist North Houston, TX

Kelly Services
The Woodlands, TX 77381
**Biopharma Validation Specialist North Houston, TX**


Kelly Science & Clinical is currently recruiting candidates for a Validation Specialist position for a Biopharma company in North Houston. This position will support process and product quality programs including process, testing, and software validation, equipment calibration programs, and process monitoring activities by writing simple verification/validation documents, executing qualification tests, compiling data, drafting summary reports, and reviewing validation documentation to ensure products are manufactured in accordance with applicable regulatory guidelines, manufacturers specifications, clients specifications, and the customers requirements. Review, update and work with various departments to develop SOPs for existing and new equipment / tests / processes.


**Responsibilities include the following:**


+ Support the validation function by assisting with the development of validation documentation, executing qualification protocols, compiling data, and writing reports.

+ Support new product scale-up, process optimization, technology transfer, and process validation activities.

+ Support QC validation of in-process and release assays

+ Support qualification and re-qualification of QC test instrumentation

+ Participate on project teams responsible for implementation of product enhancements.

+ Maintaining validation schedules/timelines

+ Maintains re-validation schedule and validation files.

+ Mentor junior staff and support team growth though the supervision of assigned projects

+ Monitor publications, presentations, etc., to stay current on all processing technology and recommend process improvements.

+ Report back to QA Manager on the general status of operations and specific issues of concern as needed.

+ Other duties may be assigned


**Qualifications:**


+ Bachelors Degree or equivalent; or one to three years related experience and/or training; or equivalent combination of education and experience.


+ Experience within a pharmaceutical/biologics environment is preferred.

+ Experience with validation / re-validation of QC assays preferred.

+ Experience with qualification / re-qualification of QC test instrumentation preferred

+ GMP experience is a plus.


This is a temp to hire position with a Monday through Friday 8am-5pm work schedule and a pay rate of $24 per hour possibly more dependent upon level of education and experience. If you meet the above qualifications, please submit your resume for immediate consideration.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-06 Expires: 2022-06-06

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Biopharma Validation Specialist North Houston, TX

Kelly Services
The Woodlands, TX 77381

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