Sr. Manufacturing Automation Engineer

The position of Senior Manufacturing Automation Engineer is within our InfectiousDisease Developed Markets Business Unit located in Scarborough, Maine. This role will beresponsible for supporting manufacturing processes, quality/cost savings initiatives andimplementation of engineering principles while assuring compliance with cGMP qualityand safety standards.

This job description will be reviewed periodically and is subject to change by management.RESPONSIBILITIES:" Carries out duties in compliance with established business policies and procedures." Demonstrates commitment to the development, implementation and effectivenessof applicable Quality Processes as per ISO, FDA, and other regulatory agencies." Responsible for exhibiting professional behavior with both internal/externalbusiness associates that reflects positively on the company and is consistent with thecompany s policies and practices." Responsibility to understand and maintain awareness of the quality consequenceswhich may occur from the improper performance of their specific job." Support department by performing related tasks as requested." Responsible for equipment specification, acquisition, and implementation." Leads automation equipment upgrade efforts related to safety, obsolescence, andcontinuous improvement initiatives." Evaluates machine logic, electromechanical and process controls to troubleshootequipment and drives to resolution." Leads teams to identify root cause of manufacturing failures using structuredproblem solving. Applies root cause fixes to prevent recurrence." Conducts failure modes and effects analysis and evaluates manufacturingequipment risk." Completes complex projects based on comprehensive knowledge of manufacturingequipment and processes." Leads design of experiments, validation, completion of testing and analysis ofdata. Presents data to cross functional teams." Drives implementation of new methods or materials for continual improvement ofquality and efficiency." Analyzes current equipment for process suitability and provides detailed plans forimprovement." Creates and revises manufacturing documents, specifications, standard operatingprocedures (SOPs), safety instructions, validation protocols, risk assessments, andprocedures and other technical documents to ensure compliant, efficient, and safeprocedures." Leads other engineers and technicians in developing solutions and improvements inmaterials, equipment, and process as necessary in addition to ensuring continualimprovement, safety, and compliance." Manages cross functional project teams and coordinate activities." Provides training and process expertise for product processing in specific areas suchas process development, tooling development, documentation, cleaning protocol,process characterization and validation." Initiates and leads to resolution of Quality Incidents and CAPA." Participates in teams as necessary and mentors junior engineers and maintenancetechnicians to ensure continual improvement, safety, and compliance." Considers safety, ergonomic, maintenance, and operator impact on manufacturingdesign." Interacts with the local Project Management Office on milestones and project statusupdates." Participates in site strategy meetings and planning." Leads change through Agile PDM." Complies with U.S. Food and Drug Administration (FDA) regulations, otherregulatory requirements, Company policies, operating procedures, processes, andtask assignments. Maintains positive and cooperative communications andcollaboration with all levels of employees, customers, contractors, and vendors.

BASIC QUALIFICATIONS | EDUCATION:" Bachelor's degree (BS) in engineering or equivalent combination of education andexperience." 7+ years engineering experience in a manufacturing environment" Experience in the application of lean six sigma principles and the DMAICapproach or a similar structured problem-solving system." Proficiency in change management principles and processes.

PREFERRED QUALIFICATIONS:" Prior experience working in a company operating under ISO, FDA, or similar qualitysystems or regulations." Experience working in a GMP, FDA, ISO and USDA regulated environment." Experience in cGMP and ISO 13485 regulations and practices." Experience in statistical analysis software." Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI,etc.)

COMPETENCIES:General Competencies:" Innovative Thinking: Independently generates new, creative, and sometimesunconventional ideas to problem solve or improve current processes and structureswhile seeking feedback from managers and coworkers." Multitasking: Demonstrates the ability to handle multiple tasks or responsibilitiessimultaneously by efficiently managing time, prioritizing tasks,and maintaining productivity across different activities" Self-Motivated: Demonstrates a proactive attitude, consistently drives personal andteam goals, and maintains high productivity with minimal external supervision." Verbal and Written Communication: Effectively conveys ideas in both individualand group settings, adapting style and methods to suit the audience s needs, bothverbally and in writing." Teamwork and Collaboration: Demonstrates professional cooperation by workingtogether harmoniously with others, being an integral part of a team, respectingothers contributions, and aligning personal goals with those of the team.Technical Competencies:" Fabrication Principles: Proficiency in fabrication principles including CNC, lathe,milling, welding, and bolted connections." Mathematical Aptitude: Proficiency in mathematical concepts such as ANSI/AQL,probability, and statistics." Technical Aptitude: Proficiency in the ability to interpret an extensive variety oftechnical instructions in mathematical or diagram form and deal with severalabstract and concrete variables." CAD: Experience in computer-aided design (CAD) and manufacturing software fordesigning system layouts." Materials Testing: Proficient in a variety of testing and measuring methods relatingto the process of evaluating the properties and performance of materials used inmanufacturing.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.