AddressSalary: $50.00 USD Hourly - $55.00 USD Hourly
Description: Title: Validation & Compliance Engineer
This job will have the following responsibilities:
- 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
• Open up Change Controls is TrackWise
• Create and update and route SDLC documents in MIDAS
• Execution of SDLC documents on site
• Route executed and reviewed Acceptance Testing and Change Control Test Plans
• Translate technical information and requirements into qualification/validation test design
• Contribute to the overall growth of PerkinElmer's compliance business
Qualifications & Requirements:
- Bachelor's Degree; scientific background
- At least 5+ years of pharmaceutical of FDA related validation experience
- Preferred Skill & Experience:
• Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
• Strong interpersonal skills and demonstrated ability to 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 a team of stakeholders
• Excellent critical thinking/analytical and problem-solving skills
• Experience with a multitude of laboratory equipment a plus
Contact:
This job and many more are available through The Judge Group. Find us on the web at
