Validation Specialist

Validation Specialist needed in Newark, DE.3+ month assignment available.Work Conditions: Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment.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 designContribute to the overall growth of PerkinElmer’s compliance businessSkills & Qualifications: Bachelor’s Degree; scientific background preferred At least 5-7 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 plusWhy Kelly ® ?As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helpingyou find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employeach 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re aleading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enablea better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide varietyof 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.