What are the responsibilities and job description for the Vice President, Facilities & Engineering position at KBI Biopharma?
TheVicePresident,FacilitiesandEngineeringisresponsibleforequipmentandsystem performance of a cGMP biologic drug substance manufacturing facility. The Vice President leads, manages, and coaches engineering, validation, metrology, maintenance, and capital project staff to ensure equipment and systems are designed, installed, qualified, and consistently perform as intended when needed. S / He develops an engaged, high performing team that demonstrates KBI core values with a culture of safety and quality.
TheVicePresidentdevelopsstrategies,processes,systems,procedures,andmetricsto achieve a high level of facility and equipment availability, reliability, and performance.
S / He monitors equipment work orders, change controls, qualification status, and readiness.Managesfacilityandengineeringprocessesassociatedwithnewproduct introductions. The Vice President is responsible for developing and implementing strategies, methods, and procedures for new and existing facilities and equipment.
TheVicePresidentworkstoensurealignmentandcoordinateswithothersitefunctions such as Finance, Manufacturing, MS&T, AFS, Process Development, and Quality Assurance. Leads efforts of the organization across functional boundaries and works with peers across a matrixed organization. Represents the functional area to clients, auditors, and inspectors.
Oversees engineering support for multiple systems, processes, and areas. Develops subject matter experts in Engineering, Validation, Metrology, and Maintenance. Applies advancedapproachestodevelopandimplementstrategies,technologies,orothermajor improvements. Directs,reviews, andapprovesengineeringdocuments.Supportmonthly reports covering overall status, key issues, and performance KPI’s.
Responsible for directing, developing, and implementing the necessary controls and systemsforthePlantEngineering,Facilities,MaintenanceandCalibration,Validation and CAPEX project functions.
Staffwillprovidetechnicaldecision-makingregardingprojectimplementationstrategies as well as requirements for projects and change controls. This includes drafting and owningriskassessments,plans,andprocedures.Staffwillberesponsibleforreviewing and approving team member’s work.
Staff member will be expected to provide exceptional customer service to internal and externalclients.Staffmusthavetheabilitytointerfaceeffectivelywithpersonnelacross quality, validation, maintenance, and other technical disciplines.
Responsibilities
- LeadsEngineering,Validation,Maintenance,andCapitalProjectsforthesite. Overseesimplementationofimprovementstoimprovesafety,reducefailures, and ensure work is completed right first time.
- Overseesmultiplecapitalprojectsandoperationalimprovementprojects, DEVs, CAPAs, and / or Change Controls while ensuring their success in meeting their respective objectives.
- EnsuresthesitealwaysremainsinspectionreadyandrepresenttheFacilities & Engineering activities during client audits and regulatory inspections.
- As a member of the Site Leadership Team works to install a Quality and Safetycultureatthesite.PerformsroutineGEMBAsacrossalldepartments and areas.
- Responsiblefortheemployment,employeemotivation,counseling,discipline, and changes in status of employees within the Facilities Engineering department. Responsible for team building, organizational development, and training.
- ResponsibleformaintainingFacilitiesEngineeringdepartmentoperationaland Capital Expense budgets.
- Ensures engineering, maintenance, and calibration procedures and systems are in a state of compliance and control. Establish and maintain a system of metricsandreportingtoevaluatetheeffectivenessoffacilityandmaintenance activities.
Minimum Requirements
The requirements listed below are intended to show the base level minimum competencies / skills required to achieve each job level within the job function. These competencies / skills are only part of the evaluation process for advancement within the job function but server as a road map for potential advancement. Other factors in the evaluation process for advancement include things such as impact, leadership qualities, experience, education, business needs, etc. These factors are documented through the evaluation process and 1 : 1 with manager.
Knowledge, Skills, Abilities :
Demonstratedtrackrecordinthefollowingkeyareas :
