Validation Specialist-Must have Pharmaceutical domain experience

PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.

• Support Compliance Projects and Programs

• 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 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 – 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

• Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment. 

Benefits at PerkinElmer

Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match