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 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

#DMS-A

#MON