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Title: Validation Specialist
Hiring Organization: Connexion Systems & Engineering
- Our client is seeking: Validation Specialist, to support Compliance Projects and Programs
Compensation, Benefits, and Employment Type
- Duration – Contract – 1 Year
- Pay rate: 50/hr.
- Job Location: West Point, PA
- Job# bh11381
- Date Posted: 09/03/2020
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 the compliance business
Job Description: this is for computer system validations and working on lab instrumentation. Looking for senior candidates with direct experience in computer systems validations, 4-5 document components on the validations. 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. 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 foundation of skills though.
- Manufacturing related instruments – used for analytical chemistry, chromatography, plate readers, mass spectrometry, titrators (no biologics, this is class analytical chemistry)
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
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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