GMP Engineering Manager (Facilities) - Marcus Center for Cellular Cures
- Employer
- Duke University
- Location
- Marcus Center for Cellular Cures (MC3)
View more
- Administrative Jobs
- Institutional & Business Affairs, Facilities Management & Sustainability
- Institution Type
- Four-Year Institution
Job Details
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
The Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an immediate opportunity for a motivated individual to join their team as a GMP Engineering Manager in their GMP manufacturing operations located at 2400 Pratt Street, Durham, N.C.
Ensure all facility systems and utilities or equipment in the Marcus Center for Cellular Cures (MC3) laboratories are installed, qualified, validated, maintained, repaired and operated in compliance with FDA regulations, applicable procedures and all other regulatory and accreditation requirements.
Function as the system owner and Subject Matter Expert (SME) for these systems. Track Preventive Maintenance (PM) and calibration schedules for these systems. Manage all contractors and vendors, annual contracts and emergency service work. This includes defining the scope of work, ensuring all work is complete in a timely manner and all documentation is thoroughly completed.
Oversee all aspects of inventory control. Manage Materials Specification Forms (MSPECs) for over 1,500 different types of supplies. Select and implement new electronic inventory management system (LIMS) to manage receipt, acceptance, storage and distribution of supplies. Apply LIMS to track expiration dates and re-ordering levels, to avoid supply shortages, and ensure appropriate levels of supplies are available to support scheduled manufacturing runs. Establish inventory procedures and policies to ensure proper control, management and reconciliation.
Respond to Facilities alarms and troubleshoot as needed. Develop emergency, short-term response plans to address alarms. Coordinate with MC3 GMP Operations Managers and with other GMP Engineering Managers to develop and implement corrective actions in response to alarms. Oversee facility construction and modifications. Act as technical resource and trainer to facilities / maintenance personnel.
Author Standard Operating Procedures (SOPs), SOP updates and deviations related to these systems. Perform root cause analysis for deviations; Determine and implement robust Corrective Action Preventative Action (CAPA) in a timely manner to prevent recurrence of issues. Manage change control process for all issues related to these systems. Lead risk assessment analysis for key changes as applicable.
Serve as back up for others GMP Engineering Managers in MC3, to cover vacation and other absences. May also oversee other staff members to support these systems.
Collaborate with MC3 GMP Manufacturing team members and with other GMP Engineering Managers to create and manage an operations schedule for materials/facilities/equipment/production logistics. Interact on a daily basis with manufacturing personnel to identify and correct deficiencies in equipment or facilitate PM program execution and improvements. Implement improvements through the change control process. Plan and execute projects from inception, design, installation, commissioning and startup.
Interface with regulatory agencies, as needed/upon request by management. Apply Good Documentation Practices (GDP) for all records, adhering to SOPs, and performing self-audits to ensure compliance
Preferred Skills:
Knowledge about basic principles of operation, calibration, qualification, validation and maintenance of GMP systems
Excellent communication, documentation and technical writing skills.
Experience working in a GMP environment, with a working knowledge of change control, investigations, deviations and CAPAs
Demonstrated project and people management skills
Experience with FDA inspections
Experience with electronic management systems
Minimum Qualifications
Education
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
Experience
8 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Organization
Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.
As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.
Duke maintains a historic affiliation with the United Methodist Church.
Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.
Mission Statement
"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'
“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.
“By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert