Validation Specialist
- Employer
- Perkin Elmer
- Location
- Santa Monica CA US
- Closing date
- Jan 25, 2018
View more
- Sector
- Pharmaceutical
- Hours
- Full Time
- Organization Type
- Corporate
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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.
Job Title: Validation SpecialistLocation: Southern California
Type of Assignment: Fulltime
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
- Contribute to the overall growth of PerkinElmer’s compliance business
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
Work Conditions:
- 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
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