**Description** Responsible for providing technical support and guidance to Operations in the solution of manufacturing and/or packaging situations while maintaining compliance with cGMP’s, safety and environmental regulations, and company standards and policies. Applies sound scientific methods and analysis, while communicating and collaborating across levels. Provides direction and guidance to shop floor personnel to achieve product/process robustness and compliance excellence. Actively participates in the coordination of process changes by being liaison to Quality Operations, Engineering, and Information Systems as required.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Assesses employee training and development needs, assesses the team in terms of knowledge and skills (cGMPs, EMEA, process, quality, safety), and makes adjustments to enhance team performance. + Leads process problem solving and ensures that root causes, corrective and preventive actions are identified and implemented to prevent recurrence. + Documents problem solving and technical assessment for deviations within the target closure time. + Evaluates deviation trends and recommends actions to achieve continuous improvement to meet Operations and Site goals. + Responsible for the write-ups of the investigations for manufacturing and/or packaging. + Performs process, systems and/or automation troubleshooting. + Evaluates and solves equipment malfunction. + Proposes equipment software/hardware changes. + Initiates and investigates test incident and problem reports. + Coordinates efforts with the IS counterpart for other computer validation and/or system administration activities. + Assures that day-to-day support is provided on the use of process automation/ computerized controls. + Responsible for providing technical support for change requests, cleaning and process validation, IQ/OQ/PQ and HAZOPS. + Participates in HAZOP studies and implements applicable process safety recommendations. + Responsible for monitoring and investigating environmental incidents such as spill and malfunctions, making thorough evaluations and recommendations to avoid recurrence. + Prepares technical documents to address regulatory compliance issues and to answer internal/ external audits, as required. + Reviews and approves technical documents as Operations representative. + Responsible for the identification and implementation of scientific and technological opportunities in manufacturing and/or packaging areas for cost, cycle time and quality improvements. + Analyzes data, recommends, designs and implements process performance improvements. + Responsible for continuous process verification activities within the department for in line products (i.e. Risk Assessments, Process Specific Trainings). + Proactive Process Analysis owner for Operations. + Executes change requests and qualifications for existing equipment. + Provides support to validation of new and existing processes, cleaning assessments and experimental trials. + Coordinates and provides technical support on new product introduction and product transfer activities, including data gathering and analysis, sampling and validation. + Assists in the development of technical training and SOPs. + Responsible to support Process Change Request process, including performing activities as required by regulatory documentation such as PCR, ECR, among others. + Complies with all environmental guidelines, procedures, training, practices, permit conditions, and internal notifications of any environmental events. + Performs other job-related duties as required. + Foster and encourage adherence to lean system metrics, design standards and performance utilizing lean tools. + Actively participates in KAIZEN events and/or lean six sigma projects. + Actively participates in daily walkthroughs and assist to the Tier 2 Board process. + Acts as key user for Production Execution for the ERP, as assigned. **Requirements** + Bachelor Degree in Science or Engineering. + Six (6) or more years of experience in production, technical or maintenance areas. + Knowledge and practical understanding of operational excellence lean six sigma, tools and methodology, highly preferred. + Willing to work irregular and/or rotating shifts. + License from PR College of Engineers and Surveyors (desirable for engineers). + Communicates clearly and concisely in English ' Spanish, orally and written. + Uses strong visual and verbal communications skills to communicate facts, figures, and ideas to others. + Knowledge of cGMPs, EMEA and Safety regulations. + Microsoft Office applications, statistical analysis software and other programs related to function. **Desired Skills, Experience and Abilities** + Minimum of three (3) years of experience in related job scope and/or supervisory experience is desirable. + Experience in SAP is highly desired. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.