Section 1: Job Description InformationJob Title : Senior Reliability EngineerDepartment : Framingham Facilities Organization (FFO)Reports To (Position) : Associate Director, Maintenance Systems and MethodsDEPARTMENT DESCRIPTIONThe Framingham Facilities Operations (FFO) department is responsible for providing corrective and preventive maintenance and support services for the building(s), equipment, and shared utilities at the Framingham site. FFO is directly responsible for the reliable, efficient, and sustained operation of the facility and all equipment. Additionally, throughdaily tasks, FFO supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements.POSITION OVERVIEW WITH KEY RESPONSIBILITIESThe Senior Reliability Engineer is responsible for increasing the reliability, sustainability, and maintainability of cGMP and non-cGMP utility and process systems. Performs detailed engineering design support for cGMP utility systems (DI, WFI, clean steam, wastewater, etc.) to support process unit operation systems (e.g. bioreactors, autoclaves, microfiltration, etc.). Also provides detailed design support for non-cGMP utilities. Actively supports the campus with the installation of new assets, continuing improvement and troubleshooting of existing assets as well as documentation updates. Performs engineering startup, factory acceptance testing, commissioning, documentation, validation support, and operator training. Develops and maintains site engineering specifications and standards. Provides cost estimates for new systems and equipment, and modifications or upgrades to existing systems. Provides load calculations on new and existing utility systems.Core Responsibilities as assignedManage Predictive Maintenance (PdM) programs (e.g., vibration, infra-red, motor circuit analysis, ultrasonics, etc.); possess the ability to understand the data output and make informed decisions on how to prioritize the corrective work from these PdM programs.
Develop engineering solutions to identified problems (including capacity, quality, cost, or regulatory compliance issues)
Perform/lead investigations and root cause analysis of repetitive problems and investigate equipment failures
Collaborate closely with maintenance personnel and system owners to understand and resolve equipment issues
Perform periodic analysis of equipment database to determine improvement
priorities; increase equipment uptime and reduce asset ownership costs.
Serve as SME for PdM and Reliability Centered Maintenance (RCM) philosophies.
Originate and develop analytical methods for determining the reliability of components, equipment, and processes.
Propose changes to the equipment maintenance plan and need for replacement
Lead actions/projects to improve, modify or replace equipment identified as “bad actors”.
Perform work within budget and schedule parameters and provide appropriate feedback to the project manager for workload, schedule, and cost management.
Perform work within applicable standards, guidelines, and procedures.
Perform and/or facilitate on-site startup and training activities.
Ensuring individual training is up to date and remains in a cGMP compliant state.
Ensuring assigned CAPA/deviation/CCR/DCR tasks are managed and resolved in a timely manner.
Execute projects with limited supervision.
Interpret and execute policies and procedures. Recommend modifications to operate policies.
Lead group of engineers and/or technicians on an ongoing or project basis.
Actively participate and provide input and feedback for the Sanofi Safety Program to meet Health and Safety regulations and OSHA requirements in all duties.
Function as a technical resource on equipment and systems; such as leading troubleshooting of operations, developing preventative maintenance procedures, and maintaining engineering documentation.
Routinely audit the operational performance and regulatory compliance of a large number of highly complex equipment components or systems.
Leads efforts with manufacturing, process development, facilities, quality assurance, and other departments in developing requirements and recommendations for system modifications.
Execute tasks, under the direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
Develop small to intermediate project scopes, schedules, and budgets.
Obtain and critique quotes for system/facility modifications and work with the vendor to execute.
Utilize quality systems to ensure compliance with regulatory requirements.
Comply with requirements from Sanofi Safety Program including Health and Safety regulations and OSHA requirements.
BASIC QUALIFICATIONSBachelor’s degree in an engineering-related field with at least 6 years of experience in Facilities Engineering or in other plant operations/support capacity or 10 years experience related to reliability engineering principles
3 years of experience in reliability engineering tools such as FMEA, RCM, MTBF, Life-Cycle costing, Pareto, and Root Cause Failure Analysis.
Familiarity with the applicable US and worldwide regulatory requirements
Knowledge of Quality Systems.
General understanding and wide application of the technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
Proficient computer skills utilizing MS Office suite applications
Familiar with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), Distributed Control Systems (DCS), and Computerized Maintenance Management systems (CMMS).
Proficient in technical writing and verbal communication skills.
Development of project execution plans for medium to large size projects
Management of small to medium size projects
PREFERRED QUALIFICATIONSWorking knowledge of pharmaceutical/biotech processes.
Working knowledge of specialized equipment/processes.
Working knowledge of utility and process equipment
General knowledge of Commissioning and Qualification.
Effectively interact with a variety of communication and working styles.
Ability to independently determine when additional internal/external resources are required to solve problems.
Certified Maintenance Reliability Professional (CMRP) certification and/or Six-Sigma experience
Experience with Deviation Management Systems (i.e., TrackWise, Phenix)
Experience with Computerized Maintenance Management Systems (i.e., Infor EAM, SAP, Maximo)
Experience working with cross-functional teams
Training, coaching, and leadership experience
SPECIAL WORKING CONDITIONSAbility to gown and gain entry to manufacturing areas.
Required to support manufacturing operations on an “on-call” 24/7 basis.
Ability to work off-shift when necessary, potentially including weekends and holidays
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SG#LI-GZPDNAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.