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19 days old

Assistant Validation Scientist

Kelly Services
Indianapolis, IN 46202
**Indianapolis Pharmaceutical Manufacturer is looking to hire a Junior Validation Engineer to work at the Indianapolis site**



**Position Overview**



Responsible for compliance with all applicable cGMP, FDA, and EU regulations as they pertain to validation (21 CFR 210 &211; 21 CFR Part 11;EU GMPs; ICH Q7, Q8, Q9, Q10).





**Major Position Activities & Responsibilities**




+ Research, write, coordinate, and execute validation protocols including IQ, OQ, and PQ for process, equipment, facility, utility, computer, and cleaning validation. Execute validation test functions in support of approved protocols. Review, summarize and present data in a Summary Report for management review and approval. Perform re-validations.

+ Use validation test equipment such as Kaye Validator, Val Probe, PLC Software such as A-B and Honeywell, and Heat Blocks.

+ Acquire and demonstrate the ability to use site documentation systems such as quality tracking systems, document management systems, training, maintenance management, etc.

+ Apply statistical tools and analyze results and raw data.

+ Participate in projects for new systems and equipment.

+ Create Standard Operating Procedures (SOPs) for new equipment/processes, as well as update existing SOPs.

+ Perform peer review of all validation documents.

+ Perform special projects and other duties as assigned.

+ As a part of the employees job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.





**Background Qualifications**




+ B.S. in science or engineering related field

+ Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment preferred

+ Expertise with Windows based Personal Computers

+ Hands-on skills are necessary

+ Above average PC skills with spreadsheets, word processing and databases.

+ Employee must be self-motivated, highly organized, and conscientious. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required.

+ Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.








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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


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




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-01-06 Expires: 2020-02-06

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Assistant Validation Scientist

Kelly Services
Indianapolis, IN 46202

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