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GMP ENGINEERING MANAGER
Job Title: GMP ENGINEERING MANAGER
Job Code: 3018
Job Level: 61
Revised Date: 09/01/2020
Job Family: JF 05
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.
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.
Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
8 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development.
Knowledge about basic principles of operation, calibration, qualification, validation and maintenance of equipment
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 preferred
Experience with electronic inventory management systems preferred
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University 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 essential job 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.