Process engineer jobs in Puerto Rico - 240 jobs

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking for talented, dedicated individuals who are committed to work under the highest standards of ethics and with expertise in the following area: Process Development Description: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision plans, conducts or monitors experiments, records and organizes data, analyses results. Generates robust and reliable data and/or ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision. Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data. Effectively transfers experimental methods from literature to the lab and makes modifications as necessary. Develops and implements new protocols with moderate review Engages coworkers in scientific discussions. Communicates data and interpretation to work group. Qualifications: Skilled at developing systems to ensure quality data. Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques. Effectively trouble-shoots equipment and experimental difficulties. Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents. Participates in department-wide support efforts such as safety, recruiting and committees. May train staff and/or supervise others. Coordinates and organizes. resources needed to complete the task. Understands when to seek input and when to make independent judgments. Competencies/Skills: Master s degree and 2 years of Scientific experience or Bachelor s degree and 4 years of Scientific experience. Working knowledge of analytical methodologies and analytical instruments qualification programs. Excellent computer technical writing skills.

Corp. Ultimate Solutions Corp. is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide. Position Summary The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test method validations, documentation review and approval, and support of quality investigations and CAPAs. The candidate will apply Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications. Responsibilities Execute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports. Perform and support test method validations to ensure compliance with intended use and regulatory requirements. Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation. Support the development, execution, and effectiveness verification of CAPAs. Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures. Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements. Develop, implement, and maintain Sampling Plans based on risk and statistical rationale. Support and execute Change Control activities, including impact assessments and cross-functional coordination. Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks. Ensure compliance with GMP, ISO, and applicable regulatory requirements. Education Bachelor's degree in Engineering or Sciences. 3-5 years of relevant experience in a regulated industry. Requirements / Skills Required experience in the Medical Device or Pharmaceutical industry. Strong knowledge and practical experience with GMP and ISO standards. Strong computer skills, including proficiency with MS Office applications (Word, Excel, Outlook) and MS Project Management tools. Solid knowledge of statistics, problem-solving methodologies, and Lean tools. Ability to work effectively in a team-based environment. Demonstrated ability to be a team player, self-starter, persistent, tactful, and persuasive. Strong organizational skills, attention to detail, analytical thinking, and accuracy. Effective verbal and written communication skills, including technical writing and presentations. Ability to work with minimal or no supervision. Fully bilingual in English and Spanish. Ultimate Solutions Corp. is an Equal Opportunity Employer.

Responsible for accessing the processes productivity challenges, generate and execute solutions following the procedures of and quality regulations of the client to assure improvement and sustainability of the results. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Assist process development activities. Performs root\-cause analysis, define and implement corrective\/preventive actions. Mitigate product failures at all stages of the client's manufacturing process. Identifies opportunities or the need for equipment, material or process changes or improvements. Provides product design reviews and feedback for manufacturability guidance. Responsible for developing process documentation and training materials for new processes, materials, and equipment process engineering and controls support. Requirements BS Degree in Engineering. One (1)) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- Proven experience working with Six Sigma\/Process Excellence Tools and Methodologies (i.e. DMAIC, Lean Manufacturing, Process Mapping, Cause & Effect, FMEA, DOE) "}}],"is Mobile":false,"iframe":"true","job Type":"Contrato","apply Name":"Apply Now","zsoid":"664728484","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Biotecnologà a"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"San Juan"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Process Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054422","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjgR1jtT5bfyqzaBW1rb2Ruw\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

Continuous Improvement Engineer II Permanent Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead. About Heraeus Medevio Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds. To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today. Position Summary The Continuous Improvement Engineer II will play a crucial role in developing and implementing global operational excellence standards and continuous improvement activities across various operational and business areas. The position involves supporting the embedding of HPS Operational Excellence principles into product and process development, training and mentoring teams, and identifying operational improvement opportunities using lean principles and 6-sigma methodology. The Continuous Improvement Engineer II also oversees IT Systems activities through coordination of HSY and is the site ERP SuperUser. What You'll Do Everyday: Demonstrating leadership in conveying operational excellence principles and developing global operational excellence standards. Implementing continuous improvement activities for various operational or business areas. Supporting the embedding of HPS Operational Excellence principles into product and process development activities and ongoing operations. Participating in the definition of HPS Global Operational Excellence standards as a member of the CI Team. Rolling out HPS Operational Excellence standards in coordination with operational leaders. Training, mentoring, and coaching engineering and operations teams on HPS Operational Excellence principles and methods. Identifying, evaluating, supporting prioritization, and implementing operational improvement opportunities using lean principles and/or 6-sigma methodology. Conducting cost/benefit analysis for changes to processes and/or equipment. Supporting the optimization of process flows, line layouts, staffing, and workstation design to improve product scalability. Leading value stream mapping exercises to identify waste and areas for improvement. Other duties as assigned. What We're Looking For: Bachelor's degree in Engineering, Industrial Engineering preferred. Minimum 4 years of experience in medical sevice or component manufacturing, as Black Belt certified preferred. Knowledge of medical device regulations, statistical analysis, design and manufacturing. Basic understanding of manufacturing equipment and computer programming. Proficiency in reading, writing and speaking English with the ability to interface and influence at all organization levels. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations. Proficient in the use of project management tools, data analytic, statistical tools, and application of continuous improvement methodologies such Lean, Six Sigma or equivalent. Ability to train, lead, mentor, coach and inspire teams to significantly impact the business. Demonstrated proficiency in strategic thinking, change management, facilitation, and interpersonal effectiveness. Proven leadership skills and business acumen; performance driven. Works with positive attitude and acts within the principle of Heraeus Core Values and Code of Conduct as applicable for position. Curious? Apply now! We are interested in finding the best candidates, and they may come from a nontraditional background. So please don't hesitate to apply, even if you aren't an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio! Any further questions? Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [[cust_RecTeam]]. Or visit us at jobs.heraeus.com.

**_What Industrial Engineering contributes to Cardinal Health_** Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Industrial Engineering is responsible for enhancing / developing processes, layout and associated tools. Identifies, analyzes and implements new or existing technology to optimize business processes. Designs process improvements to reduce cost, cycle time, improve quality and/or increase throughput. Directs external resources / contractors as required. The Principal Industrial Engineer supports Pharmaceutical Supply Chain Operations in the areas of capital project planning and management, capacity planning, operational process change, and overall distribution center operating layout optimization. The position will also support deployment of new process and automation solutions, facilitate new building designs and layouts changes. Additional responsibilities include partnering with Operations leaders, deploying capital project investments for Pharma Supply Chain Operations, and overseeing project implementation and adoption to realize improvements. **_Responsibilities_** + Drive process engineering initiatives including conceptual operational designs, layout-change scenarios, and innovative automation solutions. Work closely with business operations partners to iterate on solutioning to optimize results. Bring modernization concepts to Operations through material handling and engineering external partnerships. + Works closely with Pharmaceutical Supply Chain Operations Vice Presidents, and site leaders to manage capital projects planned within the buildings. Develops capital budget priorities, establishes preliminary budgets,business case justifications, and formalizes all capital requests for budgeted, approved, or newly scoped projects. + Leads multifunctional teams of stakeholders and contributors to deliver large complex projects on time and under budget.Coordinates with other functional groups including Corporate Real Estate,field operations, Security, Information Technology, Inventory, Quality & Regulatory, Sales,and EH&S to ensure efforts are aligned, and coordinated as projects are developed and analyzed. + Integrated team members supporting operations leadership teams to ensure that capital projects and infrastructure are deployed, coordinated, managed, and maintained to drive building performance expectations. This role also manages and executes small construction projects independent of Corporate Real Estate / Construction including all cage and vault construction resulting from expansion or relocation needs. **_Qualifications_** + Bachelor's Degree in related field or relevant work experience, preferred + 4-6 years of experience in Operations, project and budgetary management, capital investment analysis and deployment, leading complex projects with multi-functional teams, preferred + Experience with automation solutions, facility design, material handling systems, integrated warehouse controls and execution applications, preferred + Experience with AutoCAD and other software applications to drive warehouse design and concepting, preferred + Strong Leadership skills, Strong scheduling and organizational skills + Excellent technical problem-solving capability + High level of initiative - Team player + Willing and transparent communicator + Proficient with Microsoft Office Suite + Excellent written and verbal communication skills + Moderate travel to other facilities for projects and supervision of equipment installation (25%, up to 50% during specific deployment activities and project implementations) **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 3/13/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts. Project: 6 new manufacturing lines for a medical devices company in Juncos-PR Responsibilities: This role is focused on building, validating, and enabling manufacturing processes. Generate and execute validation protocols. Perform process characterization activities. Manufacturing process development. Strong candidates will demonstrate a proactive, preventive mindset, with experience establishing process capability, supporting manufacturing readiness, and working closely with MS&T or Tech Ops functions. The emphasis for this position is on upfront process design, validation execution, and ensuring processes are robust, scalable, and production-ready. Requirements: Education: Bachelor´s degree in Engineering (Mechanical, Electrical, Chemical, etc.) 2 to 5 years of minimum experience Experienced with medical devices products Process Validation (PV): characterization, OQ, PQ (non-cleaning) Equipment Qualification (CSV): URS, FAT, IQ, OQ, PQ, TMV (non-lab) Validation strategies & requirements flow-down (design → manufacturing) Risk management documentation (pFMEA) Basic statistics (Minitab preferred) Design transfer activities Design requirements validation & manufacturing controls Project-based validation experience Work Methodology: Full time special project assignment Full on-site job in Juncos, PR 5 months of special project contract Shift: Administrative and wiling to support non-standard shifts based on project needs Availability to start this work on February 1st, 2026

Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and\/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Other duties may be assigned. Responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards. This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air and HVAC. The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations. Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Requirements Minimum 5 years of experience in Utilities Equipment, Regulatory and Compliance Systems, Troubleshooting, Agile Systems, SAP Systems, Validation Qualification Phases and Commissioning. Bachelor or Technical Degree in Science or Engineering. Bilingual. Willing to work 100% on\-site in Villalba. What are the top 3 things you are looking for in a candidates experience: 1. Validation of facilities and utilities equipment including air compressor and HVAC system 2. FDA and ISO regulated industry experience 3. Operational SOP, validation protocols and maintenance plan "}}],"is Mobile":false,"iframe":"true","job Type":"Temporary","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"villalba"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00766"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016593001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26iT6OuvU0tpqTzPsm4rsMQg\-&embedsource=Google","location":"villalba","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

For Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering (Preferred Mechanical, Electrical, or Chemical) and five (5) years of experience within the Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Writing and communication skills Shift: 1st, 2nd, and according to business needs. Experience in: CAPA, Investigations, Root Cause Analyses, and Technical Writing. Risk Management (pfmea), Change Control, and Computer Software. Process, Computer validations (not cleaning processes), and Equipment document: URS, FAT, IQ, OQ, PQ. Projects (Design requirements validation, manufacturing controls). The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develops, modifies, applies, and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develops and implements methods and procedures for inspecting, testing, and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation, and reliability as they apply to product or process quality. WHO WE ARE: We are a service provider company that is different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Process Development Engineer. Requirements: * BS Engineering with at least 3 years of medical devices or pharma experience. * Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. * Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met. * Familiarity with equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/Sensors), etc. * Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data to draw meaningful conclusions. * Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes that are being developed. * Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize the risks. Also, work with PFMEA methodology for risk analysis documentation.

At Winchester Interconnect, we always do the right thing, the right way. Winchester Interconnect is committed to inspiring the most innovative teams. We foster a dynamic and inclusive environment that thrives on collaboration and continuous growth. We hire exceptional people, celebrate achievements, drive employee growth, and provide opportunities to thrive. Winchester is where potential becomes purpose, and every team member plays a vital role in building our shared success. Job Summary: As our Lean Manufacturing Engineer you will be a key change agent, responsible for analyzing, designing, and implementing lean manufacturing processes. Your primary mission will be to identify and eliminate waste, optimize workflow, and improve overall efficiency in our electronics manufacturing operations, fostering a culture of continuous improvement throughout the organization. Qualifications and requirements: Bachelor's degree in Industrial, Mechanical, Manufacturing Engineering, or a related technical field. 3 to 5 years of proven experience applying lean manufacturing methodologies in a manufacturing environment, preferably in the electronics or aerospace industry. Lean Six Sigma Certification (Green Belt or Black Belt) is highly desirable. Mastery in the application of Lean tools such as Value Stream Mapping (VSM), Kaizen, 5S, Poka-Yoke and Kanban. Speak and write both English and Spanish. Strong analytical, problem-solving, and project management skills. Knowledge of ISO9000 and AS9100 quality standards. Proficiency in Microsoft Office (Excel, Word, Access, etc.) and statistical analysis software (e.g., Minitab). Our core values Responsibility, Collaboration, and Empowerment (ACE) are the foundation of our operation and drive success. You will assume the Responsibility for the analysis of production processes to identify opportunities and will be responsible for the measurable results of its improvement initiatives. Collaborate closely with the production team, engineers, and quality staff to implement effective changes and ensure that Lean solutions are aligned with operational objectives. Empowered to challenge the status quo, lead Kaizen events, and empower teams, giving them the tools to drive continuous improvement in their own work areas. Will you be our next ACE? You will be responsible for designing and implementing lean manufacturing projects to improve safety, quality, delivery, and cost. This includes creating value stream maps, facilitating kaizen events, and implementing visual management systems on the shop floor. Finally, you will develop and monitor key performance indicators (KPIs) to measure the effectiveness of improvements, train staff in lean principles and tools, and act as a mentor to foster a continuous improvement mindset throughout the operation. Systems you will use: Google Enterprise ADP ERP Statistical analysis and process mapping software (Minitab, Visio) To get a sneak peek at some of our benefits and learn more about our career opportunities, click here ****************************** Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. In addition to the requirements of federal law, Winchester Interconnect complies with applicable state and local laws governing employment nondiscrimination in all locations where the company has facilities. Winchester Interconnect expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. ***Candidate inquiries only - No third parties accepted***

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Analyses and designs sequence of operations and workflow to improve efficiencies in plant and production facilities and equipment layouts; and establishes methods for maximum utilization of production facilities and personnel. May establish or assist in establishing accident prevention measures and may manage training programs for personnel concerning all phases of production operations. Conducts studies pertaining to cost control, cost reduction, inventory control, and production record systems. On the basis of these studies, develops and implements plans and programs for facility modifications and revisions to operating methods. May assist facilities engineers in the planning and design of facilities. Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Qualifications: Bachelor's degree in Industrial Engineering 2+ years of relevant experience Experience with agile, lean manufacturing concepts and transformations Experience in cost analysis Project management and analytical problem-solving skills Knowledge in conducting time studies and applying line balancing techniques to improve efficiency, reduce cycle times, and minimize waste. Knowledge in CAD layouts to support space utilization, product segregation and the analysis and optimization of material flow. Knowledge in Flow Acceleration Program Continuous improvement mindset Fully bilingual (English/Spanish) Available for 1st shift (40 hours per week) Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

The Senior Casting Technology Manufacturing Engineer provides technical leadership for SX or equiax investment castings across the value stream. You will partner with suppliers and cross-functional teams to drive root cause problem solving, improve producibility, increase productivity, and deliver on business objectives. You will own supplier technical relationships, coach on internal processes/specs/methods, qualify new suppliers, and help develop and industrialize alternate casting technologies. **Job Description** **Roles and Responsibilities** + Provide process and product technical leadership for the Castings commodity, including SX or equiax investment castings. + Develop strong working relationships with casting supplier technical teams. + Partner with suppliers to identify and implement corrective actions to eliminate the cause and prevent recurrence. + Act as a change agent to advance world-class performance and standard work across the supply base. + Own supplier technical relationships; mentor suppliers on GE Aerospace processes, specifications, and methods; ensure compliance and capability. + Lead cross-functional problem solving, to identify true root cause and implement sustainable corrective and preventive actions. + Improve manufacturability through design-for-casting, specification clarity, and process capability improvements. + Clearly communicate progress, risks, challenges, and countermeasures to leadership and stakeholders. + Review and approve significant/special processes; ensure adherence to standards and qualification requirements. + Collaborate with Quality and Design Engineering to ensure new and changed processes meet established metrics; align with other commodities on strategy and objectives + Partner with suppliers and internal teams to interpret drawings/specifications, ensuring conformance and clarity. + Identify and onboard new suppliers; lead technical qualifications and readiness through Manufacturing and Quality Planning reviews and support supplier Castings Audits. + Ability to travel to supplier sites 30%-50% **Minimum Required Qualifications** + Bachelor's degree in Engineering (Materials/Metallurgy, Mechanical, Manufacturing, or related field) + Minimum of 5 years of materials engineering, castings, mechanical engineering or a related field **Desired Characteristics and Experience** + Additive manufacturing experience. + Metal Injection Molding (MIM) experience. + Proficiency with Siemens NX or comparable CAD. + Sand Castings Experience. + Titanium Experience. + Significant experience in investment castings (SX or equiax), with demonstrated yield, capability, and cost improvements + Hands-on expertise across investment casting special processes (wax, shell, melt/solidification control, heat treat, HIP, NDT) and specification compliance. + Strong problem solving and project management skills. + New Product Introduction experience. + Experience maturing technologies and processes. + Excellent communication and stakeholder management; ability to influence without authority + Humble learner: Respectful, receptive to feedback, agile, and continuously improving; seeks out diverse perspectives. + Transparent communicator: Shares critical information proactively; speaks with candor; engages constructively to resolve issues. + Focused and accountable: Fast learner with strong ownership; meets commitments and drives results against SQDC targets ( _Safety, Quality, Delivery and Cost in that order)_ . **Pay and Benefits:** + The salary range for this position is $ 116,000.00 - 155,000.00. The specific salary offered to a candidate may be influenced by a variety of factors including the candidate's experience, their education, and the work location. In addition, this position is eligible for a performance bonus/variable incentive plan. + GE provides a comprehensive benefits package that provides access to plans which support the overall wellbeing of our employees and their dependents. These benefits include, but are not limited to, health care coverage (medical, dental, vision, pharmacy), a retirement plan that includes Company Retirement Savings and a 401K with Company matching, Life Insurance options, Disability coverage, paid time-off, EAP, and more. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach, a 24/7 nurse-based resource; and access to the Employee Assistance Program, providing 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Retirement Savings Plan, a tax-advantaged 401(k) savings opportunity with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. General Electric Company, Ropcor, Inc., their successors, and in some cases their affiliates, each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace, or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: * Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. * Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. * Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. * Adapts machine or equipment design to factory and production conditions. * May incorporate inspection and test requirements into the production plan. * Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. * Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. * Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. * Ensures processes and procedures are in compliance with regulations. Shift: 1st Shift Location: Villalba, PR Education: Bachelor's degree required in Engineering Preferred Qualifications: * Process Validation, Equipment IQ and Computer software validation knowledge * Technical writing knowledge and Communication skills * Investigation and root cause analysis skills Skills * Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. * Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. * Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. * Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. * Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. * Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Shift: 1st Shift Location: Villalba, PR Education: Bachelor's degree required in Engineering Preferred Qualifications: Process Validation, Equipment IQ and Computer software validation knowledge Technical writing knowledge and Communication skills Investigation and root cause analysis skills Skills Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

Permanent About Heraeus Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead. About Heraeus Medevio Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds. To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today. Position Summary The Continuous Improvement Engineer II will play a crucial role in developing and implementing global operational excellence standards and continuous improvement activities across various operational and business areas. The position involves supporting the embedding of HPS Operational Excellence principles into product and process development, training and mentoring teams, and identifying operational improvement opportunities using lean principles and 6-sigma methodology. The Continuous Improvement Engineer II also oversees IT Systems activities through coordination of HSY and is the site ERP SuperUser. What You'll Do Everyday: * Demonstrating leadership in conveying operational excellence principles and developing global operational excellence standards. * Implementing continuous improvement activities for various operational or business areas. * Supporting the embedding of HPS Operational Excellence principles into product and process development activities and ongoing operations. * Participating in the definition of HPS Global Operational Excellence standards as a member of the CI Team. * Rolling out HPS Operational Excellence standards in coordination with operational leaders. * Training, mentoring, and coaching engineering and operations teams on HPS Operational Excellence principles and methods. * Identifying, evaluating, supporting prioritization, and implementing operational improvement opportunities using lean principles and/or 6-sigma methodology. * Conducting cost/benefit analysis for changes to processes and/or equipment. * Supporting the optimization of process flows, line layouts, staffing, and workstation design to improve product scalability. * Leading value stream mapping exercises to identify waste and areas for improvement. * Other duties as assigned. What We're Looking For: * Bachelor's degree in Engineering, Industrial Engineering preferred. * Minimum 4 years of experience in medical sevice or component manufacturing, as Black Belt certified preferred. * Knowledge of medical device regulations, statistical analysis, design and manufacturing. * Basic understanding of manufacturing equipment and computer programming. * Proficiency in reading, writing and speaking English with the ability to interface and influence at all organization levels. * Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations. * Proficient in the use of project management tools, data analytic, statistical tools, and application of continuous improvement methodologies such Lean, Six Sigma or equivalent. * Ability to train, lead, mentor, coach and inspire teams to significantly impact the business. * Demonstrated proficiency in strategic thinking, change management, facilitation, and interpersonal effectiveness. * Proven leadership skills and business acumen; performance driven. * Works with positive attitude and acts within the principle of Heraeus Core Values and Code of Conduct as applicable for position. Curious? Apply now! We are interested in finding the best candidates, and they may come from a nontraditional background. So please don't hesitate to apply, even if you aren't an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio! Any further questions? Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [[cust_RecTeam]]. Or visit us at jobs.heraeus.com. ReqID: 57820

About Zenus Zenus' mission is to facilitate banking beyond borders. Operating in over 150 countries, we enable people and businesses to open a US bank account online, without the need to be a US citizen, resident, or a company registered in the US - opening up the security, stability and freedom of US banking to the world. As a signatory of the UN's Principles for Responsible Banking, we are committed to making finance fair. Our state-of-the-art technology, exclusive partnerships and proprietary processes are now being made available via our embedded banking services to enable other businesses to create new financial service experiences for their customers. Headquartered in San Juan, Puerto Rico we have a diverse and inclusive team. This position is hybrid, requiring on-site presence with a schedule of: 3 days on-site 2 days remote About the role The Security Site Reliability Engineer (SSRE) is responsible for ensuring the reliability, consistency, and continuous execution of security controls across CI/CD pipelines and cloud delivery workflows. Operating within the SecOps domain and reporting to the Information Security Officer (ISO), the SSRE focuses on automating security controls, enforcing policy-as-code, and guaranteeing that security validations always execute as designed throughout the delivery lifecycle. This role owns how security controls are executed and enforced, not application security testing, cloud configuration ownership, or service uptime. Responsibilities & duties: Integrate and maintain automated security controls within CI/CD pipelines (SAST, SCA, DAST, IaC scans). Enforce security gates and policy-as-code validations across all delivery stages. Ensure the reliability and consistency of security checks (controls never skipped or bypassed). Monitor execution health of security controls and detect failures or misconfigurations. Maintain dashboards and metrics related to security control execution (not service availability). Collaborate with AppSec to ensure application security scans are executed correctly. Collaborate with CloudSec to ensure cloud security policies are enforced during deployments. Support security incident investigations related to control failures or pipeline bypasses, under ISO guidance. Maintain automated security evidence (logs, reports, pipeline artifacts) for audit purposes (minimum 24 months). Develop and maintain SSRE runbooks, control definitions, and operational workflows. What you need for this role: 3+ years of experience in DevSecOps, security engineering, or CI/CD automation roles. Strong hands-on experience with CI/CD platforms (Azure DevOps, GitHub Actions, Jenkins). Experience integrating security scanning tools into pipelines. Knowledge of Infrastructure as Code (Terraform, Bicep, ARM) from a validation perspective. Experience with scripting and automation (Python, PowerShell, Bash). Understanding of cloud-native security concepts and delivery pipelines. Familiarity with compliance-driven environments (ISO 27001, SOC 2).

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering** **What You Will Do** Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in January 2026. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You'll work on meaningful projects and initiatives, contributing to the team's success while developing your own potential in our Operations organization centralized in Puerto Rico's End-to-End Manufacturing Site. + Measure and analyze current system and process performance. + Drive improvements in operational efficiency and productivity across the organization, maximizing AI and other technology tools. + Actively learn through on-the-job training to empower you to gain practical experience, develop new skills, and apply knowledge in real-world settings. + Identify and implement new processes across departments and functions. + Support the maintenance of detailed project plans and process performance metrics. + Participate in and lead continuous improvement initiatives. + Prepare project justifications and proposals. + Other tasks may be assigned to align with business needs. **What We Expect of You** We are all different, yet we all use our unique contributions to serve patients. We're looking for passionate and motivated individuals with these qualifications: **Basic Qualifications:** Amgen requires that all individuals applying for an undergrad internship or co-op assignment at Amgen must meet the following criteria: + Currently enrolled in a Bachelor's Degree program at an accredited college or university with a minimum 3.00 GPA. + Pursuing or have completed at least 3 years of study in Biomedical, Industrial, Mechanical, Chemical, Electrical, Software, Computer Engineering, or Life Sciences (Chemistry, Biology, Microbiology, Biotechnology, Biochemistry). + Must be enrolled in a Bachelor's degree program following the potential internship or co-op assignment. **Preferred Qualifications:** + Flexibility to participate in the program for 6 months up to 1 year. + Bilingual (English/Spanish). + Strong teamwork orientation, organizational skills, and basic project management experience, ensuring completion and follow-up. + Engagement in extracurricular activities or leadership roles. + Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, and Excel), along with strong technical writing abilities. + Excellent presentation, interpersonal, and communication skills. + Ability to meet key milestones and deliver high-quality results. + Clear understanding of Amgen values (visit our site for additional details). **What You Can Expect of Us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. + Build a network of colleagues that will endure and grow throughout your time with us and beyond. + Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. + Participate in executive and social networking events, team building activities, workshops, and more! **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for these positions; we will continue accepting applications until we receive a sufficient number or select candidates for the positions. **Sponsorship** Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Quality Sr Engineer is responsible to provide quality support for manufacturing of products as per cGMP requirements and comply with the established quality management system. The Sr Quality Engineer manages and supervise the processes like incoming quality inspections, product quality controls, investigation of customer complaints, supplier quality audits, CAPAs, and maintain quality system as per ISO13485:2018 and 21CFR 820. The Sr Quality Engineer also communicate with the cross function teams to ensure the quality system compliance, provides training to the team of inspectors. Along with experience with ISO 13485 and 21CRF820, the Sr Quality Engineer also has experience with Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211). Position Authority: This position has the authority to ensure that the nonconforming products are not accepted for manufacturing and released for distribution. The Quality Sr Engineer supervises the processes that are assigned and delivers performances to meet the goal requirements. This position motivates, and provides training for the team of inspectors to ensure timely completion of activities and compliance with the quality system procedures. Essential Job Functions: The Sr Quality Engineer is required to perform the following activities related to processes such as CAPA, Incoming Quality Inspection, QMS, and Handling of NCR; Analyze product nonconformance and customer complaints. Maintain quality management systems compliance with the regulations such as 21CFR820 and ISO13485 requirements. Trend quality performance metrics and demonstrate continuous improvements. Lead CAPAs assigned for effective closure. Initiate, review and approve SCARs. Conduct assigned Internal Audits, publish audit reports, review and approve audit responses for nonconformance(s) Coordinate, plan, perform and report Supplier Audits. Assess material risk and develop incoming inspection plans. Support preparing and participate in audits including Customer, NB audits and FDA Inspections. Review validation strategies against quality system regulation and lead quality engineering teams for the execution of validation plans for assigned quality projects. Review validation protocols and reports Interact, communicate and timely respond to the customer for Customer issued SCARs, Audit Reports, Complaints, Change Notifications, etc. Support for preparing inputs to the management review meeting. Provide technical training and support to Quality Engineers of the site as well as to Engineering Assistants and Manufacturing Engineers. Be acknowledged as a subject matter expert (SME) in at least one quality subsystem (i.e. process/software validation, complaints, NC's, other) required to providing support to the Viant. Participate and lead communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other. Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced. Responsible for the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings. Knowledge and Education: Minimum of Bachelor's Degree in Technical Field (Engineering or Sciences) is required. Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired. Knowledgeable of processes such as Quality Management System, Documentation and Record Controls, CAPA, Change Management, Quality Audits, Product Quality Nonconformance, Supplier Quality Management, Process and Software Validation is required. Knowledge of Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211). Knowledge in root cause analysis tools Proficiency in the use of MS Project. Intermediate level of knowledge of Minitab statistical software. Bilingual English/Spanish - Advanced English level (written and spoken), technical writing and capable of leading presentations. Job Experience: Minimum 5 years of Quality Engineering experience in medical device manufacturing environment and/or pharmaceutical fields is required. Demonstrated use quality tools such as GR&R, pFMEA, Control Chart, Process Capability is desired. Experience in the following processes is required; Standard regulatory requirements such as cGMP, ISO13485:2016 and 21CFR820 CAPA process Participated in internal audits A part of team supporting for 2nd and 3rd party audits and inspections Process Validations i.e. IQ, OQ, PQ, & Software Validation Statistical Analytical tools such as Process Capability, GR&R, Control Charts Risk analysis such as pFMEA\\ Skills and Competencies: Well organized, able to multitask, prioritize and manage multiple deliverables while working in a fast -pace manufacturing environment. Exudes values of being customer-centric, accountable, collaborative, and respectful and demonstrates active listening. Self-motivated, with a strong desire to learn and improve self. Excellent attention to detail and accuracy. Establishes and maintains high standards for quality and considers excellence a fundamental priority. Excellent communication skills, with the ability to create reports and presentations to influence individual or group decision-making, and to provide training to various levels of employees. Ability to delegate tasks and projects appropriately according to an individual's strengths, aptitude and career direction. Ability to motivate a team to achieve goals. Excellent analytical, technical and troubleshooting skills. Hands-on approach to problem solving. Demonstrated understanding and application of modern manufacturing principles and methods to a medical device manufacturing operation. Demonstrated proficiency with Microsoft Outlook, Microsoft Project, and Microsoft Office applications. Highly self-motivated, focused, self-starter, willing to learn, and take up new responsibility and tasks. Ability to work independently and as a part of a team. Proficiency in at least one manufacturing technical field or any quality subsystem (i.e. process/software validation, CAPA system, statistical techniques, risk management, other.) acquired through either formal training and/or work experience. Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes. Decision making: Capable of making higher risk decisions within specific value streams.

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence. Position Summary: The Quality Engineer develops and reviews documentation and procedures and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering. Key Responsibilities: Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master Validation Plans for new processes or products. Review process validation protocols and reports; support other functional areas during validation activities. Collaborate with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans and other development procedures. Design and develop in-process and receiving quality systems for new processes and components. Define gages, tools, and equipment for developed test methods. Identify and control manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in root cause analysis and implementing corrective and preventive actions. Develop product quality plans, specifications, and risk analyses (including FMEAs) in conjunction with product development teams. Develop process monitoring systems by identifying critical process steps and applying methods to reduce variation and defects. Lead process improvement efforts by capturing quality metrics and performing analysis to enhance product design and development. Assist in creating quality tools and training materials to improve effectiveness. Evaluate adequacy and compliance of systems, operations, and practices against regulations and company documentation; may serve as auditor for development and manufacturing areas. Qualifications: Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field). 2-4 years of experience in an engineering role within a regulated industry (pharmaceutical, biotech, or medical device preferred). Excellent communication (Spanish/English) and teamwork abilities. This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.