cGMP/GLP Facilities Equipment Manager (CVPF)

University Overview

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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

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.

COVID-19 vaccination or a University authorized exemption is a requirement for all positions at the University of Pennsylvania. For more information about Penn's vaccine requirements, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
cGMP/GLP Facilities Equipment Manager (CVPF)

Job Profile Title
Manager B, Research

Job Description Summary
Reporting to the Director of Facility Operations, this is a multifaceted position that fulfills Facilities related needs of the CVPF (Clinical Cell and Vaccine Production Facility), PDL (Process Development Lab), HGEL (Human Genome Editing Lab) and TCSL (Translation Correlative Studies Lab). In order to support these labs, this position must fully comply with FDA regulated cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices) and well as FACT accreditation guidelines.

Job Description

CVPF cGMP Facilities Support
The Clinical Cell and Vaccine Production Facility (CVPF) is composed of two GMP ISO certified clean room suites of 15 process rooms total, a separate Quality Control laboratory, and supporting regulatory, facilities and administrative staff totaling >50 FTE's. The Facility is a critical resource in supporting leading-edge translational research by developing, manufacturing, and testing cell and gene therapy products in clinical trials. These trials range from small early phase first-in human clinical trials to large Phase II randomized and multi-center trials in collaboration with academic and industry partners. This position maintains the CVPF facilities and equipment on SPE 9 and Ravdin 3.
This position collaborates with the Validation Manager to execute and verify qualification test cases on new cGMP equipment. The position is a Subject Matter Expert (SME) for ISO certified cleanroom Gowning Qualification team and successfully maintains gowning qualification status. This position performs preventative maintenance and calibrations on cGMP equipment following CVPF specific SOPs. This position provides emergency equipment troubleshooting and systemic remediation for critical equipment such as incubators, freezers, centrifuges, Wave bioreactors, and other cGMP equipment. Using the Rees monitoring system, this position ensures critical cGMP equipment are operating within pre-establish limits and set points. At all times, Good Documentation Practice (GDP) as written in SOP-0004 must be followed.
PDL, HGEL and TCSL GLP Facilities Support
This position also collaborates with PDL, HGEL and TCSL laboratories on SPE 9 and acts as Facilities Point of Contact (POC) for all Facilities related activities on SPE 9. This person manages new equipment requests, procurement, installation, service and retirement and supports commissioning effort on GLP equipment in PDL. The position manages preventative maintenance and calibrations for PDL equipment and maintains equipment history files in Lab Vantage. This position coordinates with PDL, HGEL, TCSL, vendors and HUP Facilities for new and demo equipment installations. This position acts as CCI primary POC for Aegis troubleshooting, new monitoring set up, training and firmware updates.
Shared cGMP and GLP Support
The position coordinates efforts with EHRS to address issues relating to safety regulations in compliance with Federal, State and University policies. This position oversees the maintenance and upkeep of laboratory space and works with the School of Medicine's Building Administrators and trades people to make sure that building and facilities issues are resolved in a timely and efficient manner. The responsibilities of this position also supports the research Facilities team activities on SPE 8 and Smilow 8.
Minimum Qualifications:.
Minimum of 4 Year College equivalent required with 3 - 4 years' experience in similar position. Previous experience in an academic laboratory and in a similar capacity is desirable. Must be reliable, able to take initiative and work independently following established procedures. Excellent organizational, written and verbal communication skills are important, as well as attention to detail and basic knowledge of computers. Understanding of GLP/GMP is required. Demonstrated ability to interact professionally with individuals of varying levels of education, experience, and job duties and to thrive in a collaborative research environment is required. Effective verbal and written communication skills are required to serve as a liaison across multi-functional groups.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$43,919.00 - $66,183.00
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
  
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
  
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
  

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/cGMP-GLP-Facilities-Equipment-Manager--CVPF-_JR00061872







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