Reliability engineer jobs in Bayamn, PR - 128 jobs

Skilled and proactive Reliability Engineer to support the Maintenance Engineering team at a leading pharmaceutical manufacturing site. The ideal candidate will be responsible for improving equipment reliability, optimizing maintenance strategies, and driving continuous improvement initiatives aligned with GMP and compliance standards. Key Responsibilities Analyze equipment failures and propose solutions to enhance reliability. Optimize preventive and corrective maintenance programs. Monitor and report on key performance indicators such as MTBF, MTTR, and OEE. Implement improvements in mechanical, electrical, and automated systems. Collaborate with cross -functional technical teams to resolve issues and execute projects. Promote safety and ensure regulatory compliance in all maintenance activities. Requirements BS Engineering Proven experience in reliability engineering within regulated industries (pharma/biotech preferred). Familiarity with tools and methodologies such as SAP PM, RCA, CMMS, and PM/PdM management. Strong analytical and problem -solving skills. Knowledge of GMP, compliance standards, and contractor policies specific to pharmaceutical environments. Excellent communication and teamwork abilities. Technical writing skills Bilingual - English & Spanish - understand, write and speak

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).

For Reliability services in the facilities and utilities area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and five (5) years of exposure in Reliability activities within the Pharmaceutical Industry. Bilingual: Spanish and English. Shift: Administrative and according to business needs. Experience in: Preventive Maintenance Optimization. Dry Product Reliability, Maintenance, and Engineering. Revision of Job Plans, Data Sheet, and SOP. Utilities and facilities. The Personality Part: If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Collect, Compile, and analyze information from manuals, iterations with the suppliers, specifications; training; systems. Gained hands-on experience in pharmaceutical dry product operations (such as tablets or capsules) ensuring equipment reliability. Participated in qualification and validation support (IQ/OQ/PQ) of new and existing dry product equipment and systems. Create Maintenance Tasks and Data Sheets. Interact closely with maintenance technicians to identify opportunities. Develop or Review job Plans using the CMMS system. Upload equipment information into the CMMS system. Evaluate and define spare parts requirements and bill of materials. Define Inventory Strategies. Design and develop Preventive Maintenance Procedures / Training. Support the development of an equipment Maintenance Strategy. 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?

Job Description 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. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Reliability Engineer Responsibilities: Conducting reliability studies and developing maintenance strategies. Analyzing data to identify areas for improvement in the reliability of equipment. Implementing preventive maintenance programs and recommending changes to enhance overall equipment reliability. Collaborating with cross-functional teams to drive reliability-centered maintenance initiatives. Identifying and prioritizing reliability improvement projects. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 2 years of experience in direct pharmaceutical, medical device or biotechnology industries. Knowledge of IBM Maximo, Maintenance Planning and Programming (MPP). General Knowlege of Equipment (Utilities and Manufacturing). Background in Reliability Engineering Preventive and Predictive Maintenance Assess system reliability using data and predictive tools Develop and Implement corrective actions Track key performance indicators (KPIs) Must be fully bilingual (English / Spanish) with excellent oral skills. Technical Writing skills. Available to work extended hours, possibility of weekends and holidays.

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"}

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.

Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing or new 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. Develop, execute, and close protocols required as part of the validation lifecycle. Supports equipment installation and assessment of inputs, outputs and alignment to requirements. Ensures processes and procedures are in compliance with regulations. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Other duties may be assigned. Resources are needed to work in new products and capacity increase projects. Main tasks will be to work with all documents of the validation lifecycle including development, execution and closure of documents\/reports. Person needs to be able to work with root cause analysis and troubleshoot process, product and equipment as needed. Requirements Minimum 2 years of experience in Validation Lifecycle in the regulated industry. Process Validation and Computer Software Validation knowledge. Experience in Equipment Validation. Bachelor Degree in Engineering Completed. Available to work 100% onsite in Ponce. Preferred Qualifications: Troubleshooting skills Validation lifecycle Root cause analysis Must be fully bilingual "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","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":"Ponce"},{"field Label":"State\/Province","uitype":1,"value":"Ponce"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00716"}],"header Name":"Process Engineer I","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016042001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26hEDGBoAZXA2hgWHHnBNaVs\-&embedsource=Google","location":"Ponce","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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

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: Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory) 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. Qualifications: Bachelor's degree in Engineering 2+ years in validation experience 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) 1st Shift, 12 Hour Day Shift, 2nd Shift Availability to work extended shifts (8- 12 hours per shift) Availability to work weekends (Saturday and/or Sundays) Availability to work Holidays as require d Availability to work first and / or second shift (If require) mainly first 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.

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 centered on sustaining manufacturing operations through investigation, compliance, and product quality assurance. Investigate manufacturing events, manage deviations or nonconformances, support product disposition decisions, and perform defect or reject trend analysis. Strong candidates will have experience reviewing and approving validation documentation, supporting sustaining manufacturing activities, and ensuring adherence to quality systems and regulatory requirements. The emphasis for this position is on reactive problem-solving, compliance oversight, and maintaining product and process conformance during ongoing production. 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

Power your Future as a Senior Distribution Planning Engineer in our Distribution Engineering department. Play a vital role in developing long-range plans, capital improvement initiatives, and reliability improvement plans for our electric utility clients. The Distribution Planning Engineer will assess distribution systems, identify patterns, and recommend actionable solutions that deliver long-term value. If you have a passion for solving complex engineering challenges in the energy sector, we encourage you to apply. Responsibilities * Analyze and provide technical support for the reliable operation of electric power grids in accordance with NERC standards and local regulations. * Develop and document engineering solutions to address issues within transmission and distribution systems, focusing on protection practices and system reliability. * Conduct coordination studies using advanced models and simulations for equipment such as breakers, reclosers, fuses, and TripSavers. * Analyze data trends, operating conditions, and system demands, making recommendations for improvements. * Perform load forecasting and scenario-based distribution planning to address system growth and stability. * Plan and perform contingency (N-1 and N-2) analyses using power flow models to solve complex system configuration and expansion challenges. * Work collaboratively with engineering and operations teams to secure and expand client projects. * Conduct reliability analyses to optimize system performance, reduce losses, and improve power quality. * Create and deliver presentations and reports to internal teams, management, and external agencies. * Assist in project management tasks, including proposals, scheduling, and estimating. * Provide expertise in distribution planning using software such as Windmil, CYME, and/or Synergi. * Travel as required to support projects and client needs. #LI-BL1 Qualifications * Education: Bachelor of Science in Electrical Engineering from an ABET-accredited program (required). * Certification: Professional Engineer (PE) in one or more states (preferred). * Experience: * Strong knowledge of electric utility transmission and distribution systems, including system protection practices. * Experience in programming and developing simulation tools such as Python (highly desirable). * Proficiency in using Microsoft Office (Word, Excel, PowerPoint, Outlook). * Familiarity with National Electrical Safety Code and IEEE standards. * Ability to perform economic decision-making analyses and interpret study results related to power flow, voltage, and system reliability. * Skills: * Excellent communication skills, both written and verbal. * Strong critical thinking, time management, and problem-solving abilities. * Ability to work both independently and as part of a team. Benefits & Compensation Qualus benefits offered include Medical, Dental, Vision, Life Insurance, Short and Long-Term Disability, 401(k) match, Flexible Spending Accounts, EAP, Parental Leave, Paid time off, and Holidays, for those who qualify. The expected compensation range for this position is based upon several factors, including but not limited to education, qualifications, prior relevant work experience and work location. Company Overview Qualus is a leading pure-play power solutions firm and innovator at the forefront of power infrastructure transformation, with differentiated capabilities across grid modernization, resiliency, security, and sustainability. The firm partners with utilities, commercial, industrial, data center, and government clients, and renewable and energy storage developers, offering comprehensive solutions through boutique and integrated advisory, planning, engineering, digital solutions, program management, and specialized field services. Qualus also provides software and technology enabled services and develops breakthrough solutions for critical power industry challenges such as distributed and variable resource integration, emergency management, and secure data exchange. The firm has over 1,800 professionals, with offices throughout the U.S. and Canada. EEO At Qualus, we believe everyone has value; and that the diversity and inclusion among our teams is what sets us apart for optimal success. We put people first because we care. To view a copy of the Qualus Equal Opportunity and Affirmative Action Policy Statement, click here. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process, and need an alternative method for applying, please email **********************.

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. 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. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group 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. #J-18808-Ljbffr

Responsible for assessing the processes quality 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 client to designs and installs quality control process sampling systems, procedures and statistical techniques. Designs and specifies inspection and testing mechanisms and equipment. Analyzes client's production limitations and standards. Recommends revision of specifications when indicated. Formulates or assists in formulating quality control policies and procedures. Develops economics of any quality control program when required. Execute and\/or approve process validation activities (test method validations, characterizations, IQ, OQ, and PQs) and process risk assessments. Requirements BS Degree in Engineering or Applied Sciences. One to five years of work experience in a similar role. Strong customer service skills are necessary. Fully bilingual "}}],"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":"Farmacéutico"},{"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":"Quality Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054462","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjlUq@IeRCLplIHBBV22Is18\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

Provides technical and 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. 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. Deep knowledge of the validation lifecycle. *Other duties may be assigned. Requirements Minimum 2 years of experience working with Validation in a regulated industry. Experience in equipment troubleshooting, process and Root Cause Analysis. Bachelor Degree in Engineering Completed. Presentation and Teamwork skills. Fully Bilingual. "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","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":"Ponce"},{"field Label":"State\/Province","uitype":1,"value":"Ponce"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00716"}],"header Name":"Process Engineer I","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015799001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26lFMfUSOIQn@v.4i65P0snE\-&embedsource=Google","location":"Ponce","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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: Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Qualifications: Bachelor's degree in engineering (Mechanical, Electrical or Chemical preferred) 4+ years of relevant experience Experience with Risk management documentation: pFMEAs Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Basic knowledge in statistics (preferably using Minitab) Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing) Experience investigating manufacturing operations events in support to product disposition Experience assessing and tracing manufacturing defects/rejects trends Knowledge in Medical Devices regulations Experience working and executing Design transfer activities Experience with projects to implement new products: design requirements validation, manufacturing controls (not Operational Excellence) Experience reviewing and approving validation test plans, reports, and deviations Capable of performing statistical analysis to support validations and product release Available for 1st 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.

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA. Job Description Support Quality Assurance program: Non Conformances Review and approve product MPs. Approve validation protocols and reports for manufacturing processes. Approve Environmental Characterization reports. Lead investigations. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Approve investigations and CAPA records. Approve change controls. Qualifications Bachelor's degree Sciences o Engineering and 3 to 5 years of directly related experience. Project management skills. Strong organizational skills. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution. Validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Ability to evaluate compliance issues. Available to work non-standard shifts requested. Fully Bilingual (Spanish & English). Additional Information Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: We are seeking a Process Engineer with strong experience in validations, including Master Validation Plans, IQ, OQ, MSA, PQ, and related activities. The candidate must be fully bilingual and have at least two years of experience in validation within a medical device company. Validation lifecycle knowledge / Hands on experience (Writing and executing IQ/OQ/PQ protocols among others) Troubleshooting equipment / process failures Analyzing test data and statistical trends Qualifications Requirements/Knowledge/Education/Skills: BBA in Enigneering At least two years of hands-on experience in validations within the medical device industry. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group 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.

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.*** Requirements Minimum 4 years of experience in the regulated industry, preferably in Medical Devices. Experience in Change control of Medical Devices, Equipment Commissioning \/ Qualification, Process Validation, CSV, Manufacturing, Packaging and Laboratory Equipment. Technical (Troubleshooting), Quality, Process Control and Assurance. Bilingual. Bachelor Degree in Engineering completed. Willing to work 100% on\-site in Juncos, PR. Top 3 things you are looking for in a candidates experience: Proficient in validation process, CSV, PV Proficient in Troubleshooting, Equipment Setups Proficient in document management "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Engineering"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016933001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26sJb6@sa8AAn7A.ZodxIbkI\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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 investigating manufacturing operations events in support to product disposition. Experience assessing and tracing manufacturing defects/rejects trends. 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.