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10081
Contract

Lab Systems Validation & Compliance Engineer - West Point, PA - 351

Location: West Point, PA, Pennsylvania

Connexion Systems and Engineering, your Boston staffing experts, would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:

 

Validation Specialist

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 

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 

 

Date Posted: 6/14/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Lab Systems Validation & Compliance Engineer

Industry: Engineering

Location: West Point, PA

Employment Type: Full Time, Contract

Pay Range:  70-71/hr.

Duration: 12 months+

Job #: bh10081

 

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ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776