Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
Provide facilities and production maintenance support including equipment maintenance, infrastructure, utilities and facility services in a Pharmaceutical manufacturing environment. Assure compliance with all regulatory requirements as related to equipment maintenance and facilities functions. Occasionally, develop maintenance strategies and insure alignment with Novartis/Sandoz Asset Management Policies.
Responsible for implementing and maintaining the Environmental, Health and Safety program in an FDA regulated pharmaceutical manufacturing environment. Responsible for identifying and implementing HSE strategies, industrial hygiene, safety and chemical regulatory requirements, training on general safety, injury reductions and emissions/ waste/ water management, including all applicable permitting and reporting requirements. Ensures systems are in place to provide for compliance with federal, state and local regulations, as well as Sandoz/Novartis Corporate standards. Act as primary liaison with Sandoz HSE and Novartis Corporate HSE regarding Fougera Pharmaceutical operations.
* Manage and supervise Plant Engineering & Maintenance staff. Provide front line leadership to site stationary engineers, electricians, and technicians. Management of third party site facility services (IFM). * Direct maintenance/engineers to establish robust maintenance systems, preventative maintenance programs, maximize equipment reliability and establish meaningful KPIs * Manage equipment reliability program to analyze maintenance data and customer information to improve preventive maintenance effectiveness. * Lead the maintenance and facilities organizations to execute preventative and corrective maintenance. * Drive continuous improvement and long-range plan for site infrastructure and utilities. * Drive energy management efficiency program. * Site liaison with outside authorities including city authorities, insurance representatives, and fire departments. * Work with engineering management team to develop and manage the facility and equipment maintenance expense budget aligned with site objectives. * Procure spare parts, manage and maintain critical spares to support facility and production and packaging equipment. * Work closely with key customers in operations, quality control and development, to ensure regulatory compliance and prompt customer service. * Communicate and collaborate with technical and management staff within Operations, Engineering, Technical Services and Quality * Provide verbal and written feedback on employee performance and set employee objectives aligned with departmental goals and employee career development. * Provide direction to subordinates based on general policies and management guidance. Work is reviewed upon completion for adequacy in meeting objectives. * Support project engineering as applicable to ensure that projects are completed on schedule and within budget. * Establish overall HSE policy, targets, goals & objectives for these sites consistent with regulatory requirements, corporate standards and Sandoz US aspirations regarding a high level of employee safety and environmental protection * Evaluate facility HSE conditions, assess risks and develop appropriate corrective action plans to address deficiencies in comparison to regulations, industry standards and company policy. Establish systems and processes that result in HSE being managed and monitored just as other aspects of the business, thereby integrating HSE into the day-to-day operations of the company. * Manage HSE audits by outside regulatory agencies * Regularly perform safety walk-throughs to proactively identify and correct potential safety issues. * Ensure job hazard analysis and/or exposure assessments are performed to identify occupational health hazards, including but not limited to hazardous chemicals and physical agents * Drive continuous improvement in HSE performance and programs. Continuously identifies enhancements or modifications to existing programs as to improve company HS&E performance and adherence to regulations. * Present technical & regulatory information to management to ensure their understanding of the regulations affecting the HSE organization and the company as a whole. Serve as company expert and resource on HSE matters. * Interface with management at all levels in order to understand and address any maintenance, environmental, or safety issues. * Direct the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities. * As appropriate, responsible for implementing and providing status updates and evidence regarding the activities/action plans for the functional requirements outlined in the Novartis Manufacturing Manual (NMM). * Other duties as assigned * Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.