Responsibilities

Support Compliance Projects and Programs

• Commissioning, Qualification, and Validation of many different types of lab instrumentation and equipment
• Technical Writing of Qualification and Validation Documents (e.g. 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
• Temperature mapping of controlled temperature
• Escort and coordinate with instrument vendor service engineers and review vendor qualification documentation
• Contribute to the overall growth of PerkinElmer’s compliance business

• 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, GAMP 5 – 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 temperature mapping and kaye validator a plus
• Experience with a multitude of laboratory equipment a plus