I. JOB SUMMARYLead facility operations team and various service contractors at the Baltimore campus. Heavy focus on coordination of corrective and preventive work planning, capital project management, department documentation, facility HEPA recertification process, and department quality systems.II. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Provide leadership and direction to facility operations personnel, driving performance and to the site function strategic plans and tasksEnsure adequate resourcing (capacity and capability) to accomplish site and EFV objectives. Recommend solutions to alleviate constraintsContinuously improve the culture of the Facility Operations teamResponsible for overseeing all day-to-day activities within the functional areas, including :o Coordination of corrective and preventative maintenance activities and ensure facility systems are maintained to an industry standard per standard operating procedures and established protocols.o Maintain the procedures within the department, and perform biennial revisions and updates as required.o Complete, review, and route for closure work requests in accordance with "Good Documentation Practices" to assure compliance with GMP.o Creation and administration of department related quality management systems, including deviations, CAPAs and change controls.o Maintain and update department SOP's, equipment records, schematics, and files.o Ensure the performance of grounds related repairs and upkeepo Participate in client and regulatory inspections for the job function areasProvide LEAN mechanics to optimize the preventive and corrective work order processes and procedures.Plan maintenance activities during facility periods including HEPA filter recertification and other downtime activities.Perform onboarding management for all equipment.Seeks ways to increase operational efficiency and the conservation of company resourcesDevelop strong relationships with internal customers and cultivate with all team membersLeadership of complex troubleshooting and problem-solving initiativesDevelop, review, and track procedure / methods / task list revisions to ensure compliant and technically sound maintenance operationsManage special projects as assigned by managementManage the department personnel within the functional areaMaintain a current and detailed knowledge of cGMPReview and approve quality documents relating to GMP activitiesThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.III. MINIMUM EDUCATION, EXPERIENCE, SKILLSBachelor of Science degree or equivalent facilities operation experience3 years of hands-on maintenance supervision or demonstrated leadership experience required7 years of general maintenance experience requiredFormal project management training preferredStrong oral, written, and listening communication skillsProficient with Microsoft Office toolsStrong knowledge of SAPMust have the ability to multi-task and coordinate workload by priority.Must be customer service and quality drivenAdvanced Requirements :Advanced training in engineering, business or project managementMember of PMI, ISPE, ASME, or AICHEEIT, PE, CAPM, PMP or LEED certificationBusiness management degree (bachelors or masters)IV. PHYSICAL / MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICSThe physical / mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.Compensation Range :110,895.00 - $166,342.00Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category
