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11 days old

Validation Specialists (medical device; pharma)

Kelly Services
Lansdale, PA 19446
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 6+ month, long term contract opportunity as a Validation Specialist for a top fortune 500 company in West Point PA.





**Title:** Validation Specialist



**Duration:** 6+ months (high likelihood of extension)



**Location:** West Point PA



**Positions Available:** 4





**Essential Duties and Responsibilities:**




+ 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.

+ Support Compliance Projects and Programs

+ 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

+ Contribute to the overall growth of clients compliance business



**Qualifications:**




+ 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





**Education / Experience:**




+ Bachelors Degree; scientific background preferred

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





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( micn083@kellyservices.com ) for immediate consideration.





**Why Kelly?**




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!


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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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: 2021-01-13 Expires: 2021-02-13

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Validation Specialists (medical device; pharma)

Kelly Services
Lansdale, PA 19446

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