Validation Specialist
Ireland | Ireland
Responsibilities
Location Limerick, IE Job ID JR-017604Support 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
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
Featured Jobs
View All of Our Available OpportunitiesRecently Viewed Jobs
Saved Jobs
Related Content
-
Community Impact
We are committed to making a difference in our communities through strategic philanthropy, partnerships and employee volunteerism. Learn More »
-
Core Values
Our achievements are built on a solid foundation of core values that inspire action, integrity, teamwork and outstanding results. Learn More »
-
Covid-19 Testing
To address growing supply constraints worldwide, PerkinElmer has expanded the production capacity of its extraction and RT-PCR tests at its global facilities... Learn More »