University of Pennsylvania VALIDATION MANAGER in Philadelphia, Pennsylvania
VALIDATION MANAGER Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.
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Reference Number 40-29769
Posted Job Title VALIDATION MANAGER
School Name Perelman School of Medicine
Posted to the Web 08/30/2018
Posted Job/Salary Grade 028
Employment Type Exempt
Position Type Full Time
Position Schedule 8-5pm
Position Length Contingent Upon Funding
Position End Date
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
This position has multiple responsibilities within the cGMP Cell Manufacturing Facilities group that supports the CVPP. Manage the Preventative Maintenance and Calibration programs to ensure all equipment (centrifuges, freezers, incubators, cell counters, etc.) remain in good working order and complaint with cGMP and FACT standards. Coordinate activities with internal scheduling and external vendors. Manage equipment repairs and risk assessments to ensure equipment remains in a qualified state.Manage the qualification of facilities and equipment in CACT and Ravdin such that they remain in a state of compliance with internal Validation Master Plans and cGMP/FACT regulatory standards. Oversee the Cleaning Validation program and support EM and personnel monitoring programs Create, execute and review IOPQ protocols for new and existing equipment.Provide oversight for compliance of the clean room facilities to ISO 14440 standards including ISO Class 5, 7 and 8 environments. Manage the BioSafety Cabinet certification program to ensure the integrity of the aseptic processing environments. Coordinate with vendors for room balancing and HEP/\ certifications. Manage the building monitoring system and annual qualification.Author, review and revise Standard Operating Procedures (SOPs) for equipment operation and maintenance. Train Manufacturing and Facilities staff on procedures. Manage Deviations from Procedure (OFPs) and Corrective Action/Preventative Actions (CAPAs) as part of the CVPF overall continuous improvement program. Ensure forms are complete and accurate.Collaborate with the Manufacturing teams to identify new equipment technologies, assess equipment capabilities and potential standards for qualification. Act as primary expert for equipment trouble-shooting.
Minimum BS in Engineering or related Science and minimum 5 – 7+ years work experience in FDA, FACT accredited or related regulatory field or an equivalent combination of education and experience required.Excellent understanding of MS Office suite, project management software and building management programs. 5+ years experience managing clean room environments such as ISO Class 5, 7 and 8 required.5+ years experience with equipment qualifications. Cleaning validation experience is a plus.5+ experience with general laboratory equipment such as centrifuges, BSCs, incubators, freezers required. Experience with high-tech equipment such as cell counters, cell washers, elutriation and micro-fluid dispensers preferred.Excellent organizational skills and ability to problem solve complex problems required. Excellent communication skills with a customer service mind set required . Ability to identify tasks, prioritize and resolve in a systematic manner required.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Quick Link http://jobs.hr.upenn.edu/postings/39772
Posting Supplemental Questions
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How did you hear about this employment opportunity?
Contacted by a Penn Recruiter
Referred by a Penn Employee
Referred by a friend or family member
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Inside Higher Ed
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What is your highest level of education completed?
Less than high school education
High School Diploma or GED
Vocational or Technical School
Associate's Degree or Two Year College
PHD/MD/JD or equivalent doctoral degree
How many years of experience do you have related to this position?
0 to 1 Year
1 to 2 Years
2 to 3 Years
3 to 5 Years
5 to 7 Years
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