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28 Oct 2020

Temporary Sr. Validation & Compliance Engineer (20-16852)

Axelon Services Corporation – Posted by iris.chen@axelon.com West Point, Pennsylvania, United States

Job Description

Job title: Validation Specialist

This role will not be remote, overall they will need to be onsite as the customer is requesting 5 days a week onsite, can be flexible as needed though. Will sit in West Point, PA. Reason for New Hire: looking to expand the teams for existing projects Job Description: This is for computer system validations and working on lab instrumentation is what we are focused on. Looking for candidates with direct experience in computer systems validations, 4-5 document components on the validations. Candidates should be Validation Analysts, focused on in lab instrumentation connected to single computer, candidate should have direct stand alone instrument experience rather than in manufacturing. They will be assigned a number of systems, each one is a small project with a customer and a client, working with vendors collecting information – will do the scheduling with vendors and doing the research on the instrument, and doing recommendations on the purchases. Looking for direct experience working in a lab with classic analytical equipment. A Pharma site with validations for analytical instruments is more in line with what we are focused on. Not a document generating writer type, this role is working with vendors and owning an “event” project and will drive the validation through completion. Need pharma/regulated environment and industry experience. We will consider candidates who have similar background who are looking to move into validation, but depends on the candidate. Really need the foundational skills though. If candidates have only worked in an enterprise environment, they need to have had direct experience working with an instrument at the limb level as well as the software level. Not a Fit: Someone who writes documents primarily is not really a fit
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 Client’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

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 56 days.

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