15 days old

Validation Engineer

Kelly Engineering Resources
Mineral Point, PA 15942
  • Job Code
Validation Engineer

1 year contract

West point, PA

50 an hour


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
* Contribute to the overall growth of PerkinElmer’s compliance business

Qualifications, Skills & Experience:
* Bachelor’s 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

Work Conditions:
* Lab Environment (may need to follow Personal Protective Equipment and Safety Polices)
* Office Environment
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 nearly 500,000 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/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.#KellyGTS]]


Posted: 2020-05-20 Expires: 2020-06-19

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Validation Engineer

Kelly Engineering Resources
Mineral Point, PA 15942

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