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Validation & Compliance Engineer

  • Location: Cambridge, Middlesex, Massachusetts
  • Salary: 55-63 per hour
  • Job Type:Contract

Posted 18 days ago

  • Sector: Information Technology
  • Contact: Daniella Adinolfi
  • Contact Email: daniella@industrial-staffing.com
  • Contact Phone: (646) 652-0984
  • Start Date: 2021-08-13
  • Job Ref: 21-12915

Job Summary
Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, specification and negotiation of competitive pricing. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors. This role is intended for use by companies in the Life Sciences and Medical Device industries and should be used for those individuals validating results for clinical research, clinical trials and manufacturing testing.

Job Description
The CSV will document and validate the deployment of Windows 10 upgrades and document changes respectively. Candidate will write, edit, route and approve appropriate documentation associated with each system upgrade and good documentation skills are a must. Candidate will need to be able to execute test protocols as needed for each upgrade. Candidate will need to be able to work on multiple projects at the same time and manage priorities. Working independently is a must. The Analyst will provide project management updates to both customer and PE management, and must be willing to travel to customer site.

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 PerkinElmers compliance business
Qualifications, Skills & Experience:
Bachelors 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 plus