Sr. Validation & Compliance Engineer in Elkton, VA at Integrated Resources, Inc

Date Posted: 12/2/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Elkton, VA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/2/2019

Job Description

Job title: Validation Specialist
Location: Client Elkton VA

Duration: Short Term 6-8 months

Job Description:
Support Compliance Project at the Client Elkton VA site.
On-Site posting
Computerized and non-computerized systems.
Data Integrity remediation for lab systems
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 *** 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