Connexion Systems and Engineering, your Boston staffing experts, would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:
Validation Specialist
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
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
Date Posted: 6/14/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Lab Systems Validation & Compliance Engineer
Industry: Engineering
Location: West Point, PA
Employment Type: Full Time, Contract
Pay Range: 70-71/hr.
Duration: 12 months+
Job #: bh10081
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776
