Sr. Validation & Compliance Engineer

Company: Stellar Consulting Group LLC
Location: Montgomery
Posted on: November 18, 2020

Job Description:

Description Sr. Validation Compliance Engineer Location 770 Sumneytown Pike, West Point PA 19486 Duration ndash Extensions are possible Interviews ndash 2-3 virtual rounds Job title Validation Specialist Location West Point, PA Job Description 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 andor 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 Job Purpose bull Support Compliance Projects and Programs bull Core Job Duties bull Design, Author, and Execute Computerized System Validation (CSV) ndash according to GAMP 5 guidance ndash especially on Analytical Laboratory Test Equipment and other Lab Information Systems bull Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design ConfigurationSpecification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents bull Translate technical information and requirements into qualificationvalidation test design bull Contribute to the overall growth of PerkinElmerrsquos compliance business bull Qualifications, Skills Experience bull Bachelorrsquos Degree scientific background preferred bull At least 3-5 years of pharmaceutical of FDA related validation experience bull Good knowledge of GMPs, 21CFR Part 11, USP 1058 ndash and other relevant industry regulations and guidance bull Strong interpersonal skills and demonstrated ability work independently bull Organized and task oriented bull Excellent written and oral communication skills ndash especially on technical topics bull Self-directed and motivated individual who is able to operate in a rapidly changing business environment bull Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal external) and ability to deal with customer complaints bull Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project bull Ability to build consensus among team of stakeholders bull Excellent critical thinkinganalytical and problem solving skills bull Experience with a multitude of laboratory equipment a plus bull Work Conditions bull Lab Environment (may need to follow Personal Protective Equipment and Safety Polices) bull Office Environment Amitav Sharma Stellar Consulting Group 197 Boston Post Road, Unit 334 Marlborough, MA 01752 Phone 703-921-4014 Fax 703-783-0505 mailto www.stellarusa.com httpwww.stellarusa.com

Keywords: Stellar Consulting Group LLC, Montgomery , Sr. Validation & Compliance Engineer, Other , Montgomery, Alabama