Description: Responsible forproviding technical support and guidance to Operations in the solution ofmanufacturing and/or packaging situations while maintaining compliance withcGMP’s, safety and environmental regulations, and company standards andpolicies. Applies sound scientific methods and analysis, while communicating andcollaborating across levels. Provides direction and guidance to shop floorpersonnel to achieve product/process robustness and compliance excellence. Activelyparticipates in the coordination of process changes by being liaison to QualityOperations, Engineering, and Information Systems as required. As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers. Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies' success. We realize that our strength and competitive advantagelie with our people. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion, mobility,networking and work-life balance. Our competitive compensation and benefitprograms reflect Boehringer Ingelheim's high regard for our employees. Duties &Responsibilities: Assesses employeetraining and development needs, assesses the team in terms of knowledge andskills (cGMPs, EMEA, process, quality, safety), and makes adjustments toenhance team performance. Leads processproblem solving and ensures that root causes, corrective and preventive actionsare identified and implemented to prevent recurrence. Documents problemsolving and technical assessment for deviations within the target closure time. Evaluates deviationtrends and recommends actions to achieve continuous improvement to meetOperations and Site goals. Responsible for thewrite-ups of the investigations for manufacturing and/or packaging. Performs process, systemsand/or automation troubleshooting. Evaluates and solvesequipment malfunction. Proposes equipmentsoftware/hardware changes. Initiates andinvestigates test incident and problem reports. Coordinates effortswith the IS counterpart for other computer validation and/or systemadministration activities. Assures thatday-to-day support is provided on the use of process automation/ computerizedcontrols. Responsible forproviding technical support for change requests, cleaning and processvalidation, IQ/OQ/PQ and HAZOPS. Participates inHAZOP studies and implements applicable process safety recommendations. Responsible formonitoring and investigating environmental incidents such as spill andmalfunctions, making thorough evaluations and recommendations to avoidrecurrence. Prepares technicaldocuments to address regulatory compliance issues and to answer internal/external audits, as required. Reviews and approvestechnical documents as Operations representative. Responsible for theidentification and implementation of scientific and technological opportunitiesin manufacturing and/or packaging areas for cost, cycle time and qualityimprovements. Analyzes data,recommends, designs and implements process performance improvements. Responsible forcontinuous process verification activities within the department for in lineproducts (i.e. Risk Assessments, Process Specific Trainings). Proactive ProcessAnalysis owner for Operations. Executes changerequests and qualifications for existing equipment. Provides support tovalidation of new and existing processes, cleaning assessments and experimentaltrials. Coordinates andprovides technical support on new product introduction and product transferactivities, including data gathering and analysis, sampling and validation. Assists in thedevelopment of technical training and SOPs. Responsible tosupport Process Change Request process, including performing activities asrequired by regulatory documentation such as PCR, ECR, among others. Complies with allenvironmental guidelines, procedures, training, practices, permit conditions,and internal notifications of any environmental events. Performs other job-relatedduties as required. Foster and encourageadherence to lean system metrics, design standards and performance utilizinglean tools. Activelyparticipates in KAIZEN events and/or lean six sigma projects. Activelyparticipates in daily walkthroughs and assist to the Tier 2 Board process. Acts as key user forProduction Execution for the ERP, as assigned. Requirements: Bachelor Degree inScience or Engineering. Six (6) or moreyears of experience in production, technical or maintenance areas. Knowledge andpractical understanding of operational excellence lean six sigma, tools andmethodology, highly preferred. Willing to workirregular and/or rotating shifts. License from PRCollege of Engineers and Surveyors (desirable for engineers). Communicates clearlyand concisely in English & Spanish, orally and written. Uses strong visualand verbal communications skills to communicate facts, figures, and ideas toothers. Knowledge of cGMPs,EMEA and Safety regulations. Microsoft Officeapplications, statistical analysis software and other programs related tofunction. 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 ishighly desired. EligibilityRequirements: Must be legallyauthorized to work in the United States without restriction. Must be willing totake a drug test and post-offer physical (if required) Must be 18 years ofage or older Who We Are: At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance.We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture.Learning and development forall employees is key because your growth is our growth.
