Validation Specialist-Remote Position– preferably the Greater San Francisco Bay or Los Angeles CA

San Francisco CA US Los Angeles CA US
May 11, 2017
Feb 02, 2018
Organization Type
Full Time

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
Type of Assignement: Fulltime 
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

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