Quality engineer jobs in Dorado, PR - 106 jobs

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_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 **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **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:** 01/20/2026 *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 (***************************************************************************************************************************

The Quality Technician will assist in the execution and documentation of quality control activities, focusing on inspection processes, document review, and support for manufacturing area(s). Responsibilities: Review production documentation per batches. Assist in the revision of incoming inspection documentation. Perform quality checks on assembly and inspection lines using established techniques. Document inspection results and escalate non-conformances. Maintain compliance with internal procedures and regulatory requirements. Apply regulatory compliance and quality practices in a regulated manufacturing work environment. Other assigned duties, as assigned. Qualifications: Bachelor´s degree in Science, Administration, Engineering, or related field. Minimum of 3 years of experience in quality assurance for manufacturing industries. Familiarity with validation documentation and inspection protocols. Detail-oriented with strong documentation and communication skills. Bilingual (English/Spanish) preferred. Work Methodology: 100% On-site and Full-time project 13 months (1st Contract) Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need). Professional services contract

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.

EQVAL Group, Inc . is a company that provides technical and engineering services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies) and other service companies. We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service. The Process Validation Engineer will support operations in a Medical Devices manufacturing environment and is expected to perform the following activities and demonstrate the following qualifications: Minimum Requirements: Bachelor's degree in Engineering. At least one (1) year of experience in Medical Device process and GMP-regulated environments (co-ops and internships are considered as experience). Experience in the design and execution of validation protocols and documentation, including URS, DS, IQ, OQ, and PQ, as well as deviation handling and report generation. Knowledge of statistical analysis (e.g., GR&R) and data management, including the use of statistical tools such as Minitab. GAP 3.0 or higher preferred. Fully bilingual in English and Spanish. Please note that this position and requires 100% on-site presence in Dorado, Puerto Rico.

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"}

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Process Engineering function is part of the Maintenance and Engineering Department that provides technical expertise and support to Dry Product Operations (DPO) ensuring compliance with cGMP, HSE guidelines and regulations, company standards and business practices. The primary areas of support include technical expertise (process and equipment), manufacturing and business process improvements, compliance with business systems, and people development. DPO technologies/processes include Wet Granulation; Roller Compaction; Tablet Compression/Coating/Inspection/Printing; Direct Compression Continuous Manufacturing; Pellet Coating and Capsule Filling/Inspection. Responsibilities: Provide DPO expertise as equipment/asset steward for the area he/she supports to maintain an efficient manufacturing processes. Establish and maintain technical information of the process and unit operations within the manufacturing process. Develop and monitor process and capacity indicators to identify and address performance issues and identify improvement opportunities. Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs). Perform troubleshooting and investigation on unexpected issues. Own equipment related deviations, CAPAs and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality, safety, environmental events. Provide technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities. Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modeling. Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub teams. Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety. Requirements: Bachelor's degree in Engineering (Chemical or Mechanical) 5+ years of experience in pharma manufacturing operations Candidates with less than 5 years of experience in pharma manufacturing can be considered and salary will be commensurate to experience EIT license required, as a minimum (member of CIAPR) Bilingual (English/Spanish) with strong written and oral communication skills Strong leadership and organizational skills Sound judgment Teamwork oriented; ability to work cross functionally Knowledge in managing multiple project objectives or assignments Technical Writing Strong customer service focus Additional Information: Available to work or provide support to a 24/7 operation, if necessary Availability to travel within and outside Puerto Rico and U.S. Work as a resource in other strategic areas of the business Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $52,500 - $154,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

ECHO Consulting Group is a highly successful and growing consulting company for the Healthcare industry for the last 12 years. ECHO offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in a work environment that values trust, respect, teamwork, creative talent, enthusiasm and diligence. Job Description Able to integrate into a dynamic cross-functional team responsible for supporting/implementing activities. Develop and execute protocols and prepare final reports following plant procedures and regulatory requirements. Analyze data, and present conclusions and recommendations to clients. Organize, schedule and track projects in order to meet client requirements within agreed time lines. Qualifications A minimum Bachelor's degree in a related science (Engineering, Chemistry, Biotechnology or Life Science) Experience working in a FDA Regulated environment. A thorough knowledge of Good Documentation Practices (cGDP), excellent verbal and written communication skills. Experience in writing technical documents, including validation documents (protocols and reports), assessments and investigations. Excellent interpersonal skills, coupled with a superb attention to detail, excellent review and analytical skills. Must have strong ability to organize and manage multiple tasks in a fast-paced environment. The ability to work effectively with team members and work under minimal supervision. Filed experience in validation equipments. Additional Information Interested send your resume to [email protected]

As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology. We are seeking an experienced Validation Engineer in Dorado, Puerto Rico. Objectives of this Role: Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies. Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources. Maintain an up-to-date knowledge of validation requirements, practices, and procedures. Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand. Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training. Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results. Skills and Qualifications: • More than 5 years of experience in the industry (preferably with experience in medical devices). • Experience executing semi-automatic equipment validations (Debug, IQ/SQ, Process Characterization, OQ/PQ, etc.). • Technical knowledge. • Knowledge of software and/or PLC is an advantage. • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early. • Willing to work overtime or weekends if necessary. Our Benefits: Health, Dental, and Vision Insurance Benefits Training Opportunities and Career Development 401k plan with Employer Contributions PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!

Our client, a leader in manufacturing components for electrical devices such as switches (breakers) and control systems, uses molding and metal stamping processes for customers in the appliance and electronics sectors. They specialize in the production of high-precision parts for assembly and work with advanced technology. They are seeking a Process Engineer (Injection Molding). Job Summary: We are seeking a highly skilled and experienced Process Engineer with a strong background in the sector, optimizes, and troubleshoots injection molding processes for high-quality, efficient production, focusing on scientific molding, process validation, data analysis, tooling integration, and leading continuous improvement activities using Lean methodologies (SMED, TPM) , while also mentoring and coordinating tool-shop and maintenance operators. The person will be also involved in the preparation of new products launches and cost analysis . Key Responsibilities Process Development & Optimization: Establish and refine molding parameters, develop new processes for new products, and implement changes for better quality, cycle time, and efficiency. Troubleshooting: Diagnose and resolve complex material, tooling, equipment, and process issues. Validation & Documentation: Perform validations, conduct process capability studies, and maintain accurate process documentation (process sheets, work instructions). Tooling & Equipment: Supervise and mentor toolmakers, maintenance mechanics, and other technical personnel. Provide hands-on leadership in troubleshooting, repairing, and maintaining tools and equipment in good conditions. Ensure that team members are working efficiently and safely. Monitor and analyze Key Performance Indicators (KPIs) and Overall Equipment Efficiency (OEE) to identify performance gaps and implement corrective actions. Work closely with operations teams to meet or exceed production goals and quality standards. Assist in the preparation and production of various plastic components and systems, ensuring that processes run smoothly and meet customer specifications. Provide support during equipment setups, process validations, and production runs. Work closely with cross-functional teams (including quality, planning, production, maintenence) to ensure that products are manufactured to specifications. Participate in team meetings and provide technical input for product improvements or process changes. Leadership & Training: Provide technical leadership, mentor technicians and operators, and train personnel on new processes and best practices. Qualifications: Education: Degree in Mechanical/Industrial Engineering or related field. Experience: Several years of experience and a solid background in injection molding, tool design and maintaining, process development, and new product introduction (NPI) Technical Skills: Proficient in scientific molding principles, data analysis, Moldflow (optional but beneficial), robotics (optional), and validation protocols. Methodologies: Knowledge of Lean Manufacturing (SMED, OEE, TPM) , Root Cause Analysis (8D, CAPA, Pareto). Soft Skills: Strong problem-solving, leadership, communication, attention to detail, and ability to work in a fast-paced environment with a sense of urgency and proactivity. Availability to occasionally travel for customer visits outside Puerto Rico and/or for technical support and site visits, in case of need

For Validation services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree and or an equivalent of three (3) years of experience in Industrial and Construction projects within the regulated industry. Bilingual (Spanish and English). Good organizational and problem-solving skills. Shift: First (Monday-Friday) & according to business needs. Experience in: Process Validation and Development. FDA, GMP, and ISO guidelines. Statistical techniques (DOE, SPC). Computer software knowledge (Microsoft Word, Excel, Power Point). 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, manages, and executes cost improvement, product/process, and technology transfer projects. Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters. Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities. Conduct process equipment installation/operational/performance qualification studies to test their functionality . Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment. Other duties as assigned. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in 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 Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who 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. Job Description Key Responsibilities: Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment. Coordinate FAT/SAT execution and documentation with vendors and engineering teams. Perform field inspections, loop checks, and functional verifications during commissioning. Ensure equipment is installed and operates per design specifications, user requirements, and cGMP standards. Support resolution of deviations and discrepancies identified during commissioning and qualification. Author and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports. Interface with validation, manufacturing, automation, and QA to ensure alignment and timely execution of CQV activities. Participate in change control evaluations and equipment impact assessments. Downstream Equipment in Scope: Chromatography Skids. Tangential Flow Filtration (TFF) systems. Depth filtration units. Centrifuges and continuous flow centrifuges. Virus filtration and inactivation systems. Bulk product hold tanks and transfer skids. Clean-in-place (CIP) and Steam-in-place (SIP) systems. Qualifications Qualifications: Bachelor's degree in engineering, biotechnology, or related life sciences discipline. 3-7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment. Strong understanding of downstream unit operations and associated automation. Proficient in writing and executing validation protocols and working within electronic validation systems (e.g., Valgenesis, Kneat). Familiarity with FDA, EMA, and ICH guidelines. Excellent communication and documentation skills. Preferred Skills: Experience with single-use technologies (SUT) in downstream processing. Knowledge of DeltaV, Rockwell, or Siemens PLC-based automation systems. Experience working on greenfield or facility expansion projects.

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: Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory). Experience in production line. Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing). Experience with Risk Management documentation: pFMEAs. Basic knowledge in statistics (preferably using Minitab). Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence). Qualifications: Bachelor's degree in Engineering (Mechanical, Electrical or Chemical preferred) Minimum of 2 years of Engineering experience. Knowledge in Medical Devices regulations. Experience in GMP documentation. Experience working and executing Design transfer activities. Must be available to work all shifts, weekends and overtime. Availability to work extended shifts (8- 12 hours per shift) 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.

A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr

**_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 (***************************************************************************************************************************

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 Validation Engineer - Process Development. 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. * Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. * Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. * Design and develop in-process and receiving quality systems for new processes and components. * Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. * Define gages, tools and equipment for the test methods developed. * Generate manufacturing instructions for new processes being developed. * Work cross-functionally with other departments to accomplish PD tasks.

The Manufacturing Engineer is responsible for designing, developing, validating, and sustaining manufacturing processes, equipment, and systems to ensure efficient, compliant, and high-quality production. This role functions as an established individual contributor, supporting moderately complex projects and cross-functional initiatives within a regulated manufacturing environment. Key Responsibilities Responsibilities may include the following and other duties may be assigned: Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations. Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance. Adapt machine and equipment designs to meet factory and production conditions. Incorporate inspection and testing requirements into production and validation plans. Perform process and equipment performance evaluations to verify efficiency, capability, and compliance. Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality. Provide technical and sustaining engineering support to manufacturing operations. Develop and support manufacturing processes applicable to Statistical Process Control (SPC). Apply statistical techniques to analyze process performance and drive continuous improvement. Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements. Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities. Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques. Participate in cross-functional meetings and project teams to meet operational and project objectives. Support project scheduling and execution to ensure deadlines are met without operational impact. May mentor or provide guidance to entry-level engineers or support personnel. Requirements: Education Bachelor's degree required in Engineering Minimum of 2 years of relevant manufacturing engineering experience in the regulated industry. Technical Knowledge & Skills Knowledge of Process Validation, Equipment IQ, and Computer Software Validation Experience conducting investigations and root cause analysis in manufacturing environments Knowledge of statistical techniques and Statistical Process Control (SPC) Ability to evaluate machinery, equipment, and tools to verify performance and efficiency Experience supporting technical and sustaining engineering activities Work Methodology: 100% On-Site in Villalba, PR Full time job Professional services or W2 Temp job classification Administrative shift from Monday to Friday (8am-5pm) 6 months of 1st contract up to 2 years based on performance and budget

Responsible for designing, executing, and document equipment and processes validations following procedures of and quality regulations of the client. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Develop and execute IQ, OQ, and PQ protocols for product, processes, facilities, software and equipment within the client's facility. Review existing validation reports and identifies gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Provide guidance and understanding on all equipment qualification methodologies as required by Pharmaceutical\/Medical Device industry within client's site. Participates on project teams to create and\/or approve (as applicable) the following: equipment & software risk management documentation, equipment design reviews, equipment verification and validation documentation. Support manufacturing\/quality\/engineering teams in the area of Process Validation to ensure that equipment related risks are identified and mitigated accordingly through testing. Assist in risk assessment activities (i.e. process map, value stream map, fish bone diagram, etc.) for equipment improvements or new equipment\/process development. Support activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with client's specifications. Requirements BS Degree in Engineering or Applied Sciences. One (1) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- Proven experience working with problem solving skills and familiarity with DMAIC problem solving tools. "}}],"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":"Industrial"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Validation Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054025","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjrPYKQrk3zx6cpCvFlkiYYk\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

Job Description As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology. We are seeking an experienced Validation Engineer in Dorado, Puerto Rico. Objectives of this Role: Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies. Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources. Maintain an up-to-date knowledge of validation requirements, practices, and procedures. Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand. Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training. Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results. Skills and Qualifications: • More than 5 years of experience in the industry (preferably with experience in medical devices). • Experience executing semi-automatic equipment validations (Debug, IQ/SQ, Process Characterization, OQ/PQ, etc.). • Technical knowledge. • Knowledge of software and/or PLC is an advantage. • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early. • Willing to work overtime or weekends if necessary. Our Benefits: Health, Dental, and Vision Insurance Benefits Training Opportunities and Career Development 401k plan with Employer Contributions PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who 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. Job Description Senior Validation Specialist - Utilities and Facilities Position Summary The Senior Validation Specialist for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. The Validation Specialist ensures compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness. Key Responsibilities: 1. Commissioning Activities Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed air) and facilities (e.g., cleanrooms, environmental monitoring systems). Conduct FAT, SAT, and pre-qualification tests to verify system functionality. Troubleshoot and resolve technical issues during the commissioning phase. 2. Qualification & Validation Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities. Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification. Ensure systems meet performance requirements and GMP standards. Perform thermal mapping, pressure testing, and other critical tests as needed. 3. Documentation Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs. Document deviations, CAPAs, and change controls associated with facilities and utilities systems. Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP). 4. Compliance and Risk Management Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO). Perform risk assessments and develop mitigation strategies for utility and facility systems. Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards. 5. Lifecycle Management Oversee requalification and periodic review of utilities and facilities systems. Manage system upgrades, decommissioning, and retrofits while ensuring GMP compliance. Collaborate with engineering and maintenance teams to ensure ongoing system reliability. 6. Cross-Functional Collaboration Partner with engineering, facilities, quality, and validation teams to ensure successful project execution. Coordinate with vendors and contractors during equipment installation and qualification. Provide support during internal and external audits and inspections. 7. Training Train facility and maintenance personnel on the operation and maintenance of qualified utilities and facilities. Skills Strong technical writing skills for protocol and report development. Proficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters). Excellent organizational and project management skills. Effective communication and troubleshooting abilities. Knowledge In-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities. Familiarity with validation guidelines (e.g., ICH Q9, ASTM E2500). Understanding of cleanroom classification and monitoring (ISO 14644-1, EU GMP Annex 1). Working Conditions Manufacturing plant and utility environments, including cleanrooms. Occasional travel for vendor FATs or external inspections. Flexibility to work extended hours or weekends during critical project phases. Qualifications Education Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field. Experience Minimum 8 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment. Hands-on experience with systems such as HVAC, purified water, clean steam, compressed air, and cleanrooms. Familiarity with environmental monitoring and building management systems (BMS) Certification in validation or engineering disciplines (e.g., ISPE, ASHRAE). Experience with utilities automation systems (e.g., SCADA, PLCs). Knowledge of energy efficiency principles and sustainability practices for facility systems. Additional Information All your information will be kept confidential according to EEO guidelines.