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Validation and Compliance Engineer
Newark, Delaware - Posted on October 8, 2019
Published By Laura Sweeney

Now hiring a Validation & Compliance Engineer in Newark, Delaware!

Job Description

Trillium Technical is seeking a Validation & Compliance Engineer in the Newark area.

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

If you’re interested in this Validation & Compliance Engineer position and meet the qualifications below, please apply today!

Qualifications

• Bachelor’s 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


Trillium has been recruiting and placing professionals for over 30 years. From Fortune 100 companies to small businesses, our philosophy remains the same: to achieve excellence by providing quality employees and an uncompromising level of service. We believe in honesty, integrity, and a simple philosophy of providing value to our customers and our employees. We strive to be unsurpassed in the recruitment and placement of quality and skilled professionals. Trillium is an Equal Opportunity Employer.

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