Associate Manager Utilities-Pharmaceutical Industry

Follow Your Genki to North Americas largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important"”and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.Join usWe are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.About This RoleThe Associate Manager of Utility Operations ensures the efficiency and operational reliability of the Utilities and Controls that support side-wide equipment and facility systems through Preventive and Corrective Maintenance practices. This role manages the development of the utility operators as the sitetransitions from construction to operation. This role also assists with establishing efficient programs designed fit for future operations by utilizing knowledge of current good manufacturing practice (cGMP) and good laboratory practice (GLP) compliance, utility operations and maintenance programs, work scheduling, and equipment repair and troubleshooting. Additionally, this role provides day-to-day oversight and development of the Utilities team.What You'll DoAssists with developing the team's strategy and schedule needed for operationsLeads the transition from construction to operations for the utility systems by defining operational procedures and processesManages and develops utility technicians and operators across all aspects of personnel managementCollaborates with leadership to develop, implement, and perform tasks for the FDBN Utility Operations Program (e.g., establishes procedures, troubleshooting and repairs, access requirements, etc.)Supports analysis of equipment breakdowns (failure analysis) to determine root cause and makes recommendations to eliminate future breakdownsParticipates on emergency response teams (ERTs) and other process improvement teams, as requiredLeads root cause investigations and corrective and preventive actions (CAPAs)Supports project engineering with design, installation, and validation of new plant system equipment, including facility, process, and laboratory utility systemsInterfaces with other maintenance and technical functions (e.g., Instrumentation & Controls, Manufacturing, Engineering, Spare Parts, Validation, Quality, and external suppliers) to provide a high level of excellence supportActs as an operations advocate, removes barriers, enables processes to run optimally, and coordinates daily scheduleServes as a coach and technical mentor for technicians and operators to foster professional developmentAddresses employee concerns, questions, and performance, and partners with HR, as needed for resolutionExecutes process confirmation of standards used on shift and works with process teams on ideas to proactively improve quality and compliance while implementing process improvementsEnsures control room technicians and operators follow processes through appropriate training and verifies solutions are mapped to work and communicated across shiftsReviews and closes work orders completed by the utility operators and maintenance teamsEnsures operational tasks are properly documented in logbooks, pass downs, and work ordersDevelops a process to ensure updates, changes, and any information is accurately communicated to all employees across shiftsEnforces all safety and environmental requirements and company policies (e.g., time off, shift work, inclement weather) that directly impact employeesParticipates in the recruitment process and retention strategies to attract and retain talentCompletes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.)Participates in site visits to FDB global locations for knowledge sharing and learning of best practicesOther duties, as assignedKnowledge and SkillsKnowledge of operations and maintenance performed on GMP and non-GMP utility equipmentKnowledge of engineers and operations general principals, and tools or equipment associated with calibrationEffective communication, both written and oralStrong analytical and problem-solving skillsAbility to work in a fast-paced environmentAbility to lead a team and manage multiple projects simultaneouslyKnowledge of Microsoft Office (e.g., Word, Excel, Outlook, PowerPoint)Ability to effectively present complex information to othersAbility to adapt and be flexible with schedule to effectively communicate and manage teams on shiftFlexibility to provide on-call support to 24/7 operations and maintenance teamsTravel required, up to 10%Basic RequirementsHigh School Diploma/GED with 12 years of operations or maintenance experience; orAssociate degree in Engineering, Life Sciences, or relevant field with 10 years of operations or maintenance experience; orBachelor's degree in Engineering, Life Sciences, or relevant field with 8 years of operations or maintenance experienceExperience working in a cGMP environment1-2 years of managing a team of utility operators or techniciansPreferred Requirements / CertificatesBachelor's degree in Engineering, Life Sciences, or relevant fieldExperience working in utility operations within the biotechnology or pharmaceutical industryLean Six Sigma or other process improvement certificationBioWork CertificationFDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Created: 2024-11-01