Connexion strives to be the unrivaled staffing solution for both job seekers and hiring organizations by expertly connecting talent with opportunity. We build world class teams for our customers, and better the lives of our candidates by providing them with fulfilling careers.
Connexion would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:
Validation & Compliance Engineer (CSV)
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 our compliance business
Skills & 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
Date Posted: 9/10/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Validation & Compliance Engineer
Location: Newark, DE
Employment Type: Full Time, Contract
Pay Range: 50-52/hr.
Duration: 4-6 months +
Job #: bh10404
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776