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Validation Specialist - United States  

PerkinElmer (company)

Posted on : 14 May 2017

Project Description

Job Type : Contract
Career Level : Experienced (Non-Manager)
Education : Bachelor's Degree
Location : 1. Los Angeles CA US
2. San Francisco CA US
Job Description :

PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.

Job Title: Validation Specialist
Location: Remote Home Based Position in the West Coast (CA) – preferably the Greater San Francisco Bay or Los Angeles Areas
Duration: Long Term
Job Description:
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 Qualification Protocols (IQOQ), Calibration Procedures, and other instrument support documents
  • Pre-Qualification/Validation activities, such as system risk assessments
  • 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.  

Benefits at PerkinElmer

Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match