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18 days old

SE14 - Scientist

Kelly Services
Lansdale, PA 19446
Job title: Validation Engineer/Compliance Specialist



Location: West Point, PA



Job Description Summary



Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors. This role is intended for use by companies in the Life Sciences and Medical Device industries and should be used for those individuals validating results for clinical research, clinical trials and manufacturing testing.





Job Purpose:



Support Compliance Projects and Programs





Core Job Duties:



Design, Author, and Execute Computerized System Validation (CSV) according to GAMP 5 guidance especially on Analytical Laboratory Test Equipment and other Lab Information Systems



Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents



Translate technical information and requirements into qualification/validation test design





Qualifications, Skills & Experience:



Bachelors Degree; scientific background preferred



At least 3-5 years of pharmaceutical of FDA related validation experience



Good knowledge of GMPs, 21CFR Part 11, USP 1058 and other relevant industry regulations and guidance



Strong interpersonal skills and demonstrated ability work independently



Organized and task oriented



Excellent written and oral communication skills especially on technical topics



Self-directed and motivated individual who is able to operate in a rapidly changing business environment



Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints



Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project



Ability to build consensus among team of stakeholders



Excellent critical thinking/analytical and problem solving skills



Experience with a multitude of laboratory equipment a plus





At Kelly Services, we work with the best. Our clients include 99 of the Fortune 100 companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.




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



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-13 Expires: 2020-12-14

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SE14 - Scientist

Kelly Services
Lansdale, PA 19446

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