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Jobs in Arroyo, PR

  • LL01-102225 C&Q Lead - Filling Operations

    Validation & Engineering Group

    Humacao, PR

    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: The C&Q Lead - Filling Operations: responsible for planning, executing, and managing all Commissioning and Qualification (C&Q) activities associated with aseptic Filling Lines and Support Systems in a GMP-regulated biotech facility. This role ensures that equipment, systems, and utilities are installed, commissioned, and qualified per design intent, user requirements, and regulatory expectations to support successful start-up and commercial readiness. Key Responsibilities: Project Leadership & Planning Lead and coordinate C&Q scope for Filling Operations, including: Isolator-based filling lines (vials, syringes, cartridges) Lyophilizers Autoclaves, washers, depyrogenation tunnels Associated utilities (WFI, clean steam, HVAC, compressed air) Develop and maintain the C&Q Master Plan and schedule for filling area systems. Interface closely with Process Engineering, Validation, QA, and Operations to align priorities and readiness milestones. Ensure adherence to GMP, GEP, and corporate engineering standards. Commissioning & Qualification Execution Oversee development and approval of URS, FAT, SAT, IOQ protocols, and summary reports. Coordinate vendor FAT/SAT and punch-list resolution. Lead execution of C&Q testing for mechanical, automation, and process integration. Ensure robust data integrity and proper documentation within electronic validation systems (e.g., Kneat or ValGenesis). Manage Change Control and Deviation resolution related to equipment qualification. Technical Oversight Serve as technical SME for aseptic filling equipment and integration with isolator technology and automation. Review and approve critical design and test documents (P&IDs, specifications, FDS/HDS/SDS, test scripts). Ensure utilities and equipment meet FDA, EMA, and Annex 1 standards for aseptic manufacturing. Ensure C&Q documentation meets regulatory expectations and site quality standards. Support Quality Assurance in audits and regulatory inspections related to facilities, utilities, and filling equipment. Prepare and present C&Q metrics and readiness reports to site and project leadership. Cross-functional Collaboration Work closely with QA Validation, Automation, Process Engineering, and Operations to ensure smooth tech transfer and startup. Participate in project risk assessments, design reviews, and qualification readiness reviews. Mentor junior C&Q engineers and ensure consistent execution practices. Qualifications: Education Bachelor's degree in Engineering (Mechanical, Chemical, or related discipline) or equivalent technical background. Experience 8+ years of experience in Commissioning & Qualification within biotech or pharmaceutical manufacturing. Minimum 3 years leading C&Q for aseptic filling or sterile manufacturing operations. Strong knowledge of GMPs, GEPs, ASTM E2500, ISPE Baseline Guides, and Annex 1. Technical Skills Experience with isolator-based filling systems, lyophilizers, and sterile utilities. Familiarity with automation integration (DeltaV, SCADA, BMS) and data integrity requirements. Hands-on experience with electronic validation platforms (e.g., Kneat, ValGenesis). Excellent communication and leadership skills. Preferred Experience in start-up or greenfield projects for biotech/sterile manufacturing sites. Demonstrated ability to lead multidisciplinary teams in GMP facilities.
    $59k-73k yearly est.
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  • Handyman - Construction

    Mentor Technical Group 4.7company rating

    Guayama, PR

    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: Carry out a wide range of repair and maintenance tasks such as, plumbing, carpentry, light electrical, masonry plaster and office fixtures/equipment installation among others. Trained and with the skills necessaries to provide a wide range of repairs, maintenance work, facilities services, plumbing work, ceiling and floor repairs, small civil work in compliance with the facilities cGMP regulations and safety requirements. Perform work involving maintenance/craft skills to carry out general maintenance including: building and site repairs, fencing, painting, floor and wall tiling, cleaning footpaths, rubbish and recycling bins, etc. Deal with general items of repair and maintenance in the interior and exterior of the building: e.g. putting up shelves, changing light bulbs, moving furniture, cleaning lamp shades, cleaning windows. Carrying out routine checks, repairs and maintenance of site equipment, and the exterior of the building. Educational and Requirements: Driver's license of PR Position Qualifications AD in Technical Field Preferred 3-5 Years of Experience in Facilities and Regulated Environment (Preferred) Capability to Work Alone 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.
    $69k-81k yearly est. Auto-Apply
  • Quality Application Specialist

    Mg Staffing Group

    Juncos, PR

    Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers\/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques. Performs system administration and configuration of quality information technology systems. Perform other duties assigned. Requirements Minimum 5 years of experience in the regulated industry. Experience in with Process Validation and Computer System Validation. Experience in Medical Devices Regulatory and Technical background. Bachelor Degree in Science or Engineering completed. Bilingual. Willing to work 100% On\-site in Juncos, PR. "}}],"is Mobile":false,"iframe":"true","job Type":"Temporary","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Pharma\/Biotech\/Clinical Research"},{"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":"Quality Application Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016606075","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26oSny.cUHnThVWu2oCqo1WQ\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}
    $60k-78k yearly est.
  • Jt063 - Project Coordinator II

    Quality Consulting Group

    Juncos, PR

    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: Oversee the planning, coordination, and management of spare parts inventory and logistics to support efficient operations and maintenance. Collaboration with cross-functional teams to forecast demand, ensure timely procurement, and maintain optimal stock levels. Track and manage inventory, resolve supply chain challenges, and ensure the availability of critical components to meet operational needs. Analyse data to improve processes, document workflows, and support strategic decision-making. Provides project or program support to a functional group or business process. Monitors program/project/system status, budgets and timetables. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding. Qualifications: Bachelor's degree in Business Administration, Project Management, or related field Minimum of 2 years of relevant experience. Full job knowledge of systems and procedures obtained through prior work experience or education. Experience in project coordination or product management Proficiency SAP, Microsoft Office, project management software. Strong organizational and time management skills. Excellent communication and interpersonal abilities. Ability to work collaboratively in a fast-paced environment. Shift: 4th shift starting at 5:00pm - 5:00am (12-hour rotation 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.
    $28k-53k yearly est. Auto-Apply
  • Validation Specialist

    Ultimate Solutions 3.6company rating

    Caguas, PR

    Education: Engineer, Science Related. IE Prefered Years of Experience: 3-5 Skills: Statiscal data Analyst and Six Sigma Green Belt Certified - Prefered Knolwlwdge in Validations Strategies Development and Implementations Product Tranfers Computer Validation Lifecycle among others Leader with great interpersonal skills Fully Bilingual
    $61k-76k yearly est.
  • Project Scheduler Consultant

    Flexible & Integrated Technical Services

    Juncos, PR

    For Scheduling services in the Capital Project area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Science with more than five (5+) years of exposure in Scheduling roles within the Pharmaceutical or Medical Device Industry. Experience in: MS Project Software Develop Master Schedule 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 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) Create, monitor, and analyze project schedules in accordance with standard of best project practice Track, analyze, and report information appropriately to allow the project teams to manage their projects and evaluate weekly reports. Ensure accuracy of project schedules and performed version control. Co-ordinate project schedules, tasks, meeting updates, and efficient distribution of reports. Prepare, implement, and monitor scopes of work for control and integrity. Monitor projects' progress, including identifying critical activities and reviewing forecasts and progress achieved to date. Maintain project risk register to ensure that risks are effectively managed to minimize their impact on schedule, scope, and budget of projects. Track baselines perform what-if analysis and develop contingency plans. Develop and implement applicable communication strategy and metrics. BEING A FITS PIECE COMES WITH PERKS: One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you'll be amazed). However, that's not all we have to offer. Talk with us to find out! 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?
    $30k-43k yearly est. Auto-Apply
  • Licensed Pharmacist

    QRC Group 4.3company rating

    Caguas, PR

    The Licensed Pharmacist is responsible for ensuring compliance with all applicable pharmaceutical regulations, Good Manufacturing Practices (GMP), and company policies. This role oversees the proper handling, storage, and distribution of pharmaceutical products, guarantees adherence to regulatory requirements, and serves as the primary liaison with health authorities. The Pharmacist -in -Charge ensures that all operations maintain product integrity, patient safety, and legal compliance. Key Responsibilities: Act as the Pharmacist -in -Charge for the site, maintaining an active professional license in accordance with local regulations. Ensure compliance with FDA, EMA, ICH, and local health authority requirements. Oversee the receipt, storage, and dispensing of raw materials and finished products. Review and approve batch records, labeling, and documentation for accuracy and compliance. Monitor and enforce adherence to GMP, SOPs, and quality standards throughout the facility. Participate in audits and inspections, providing documentation and regulatory expertise. Train and mentor staff on pharmaceutical regulations and best practices. Manage controlled substances in compliance with legal and regulatory requirements. Support validation, quality control, and regulatory submissions as needed. Requirements Bachelor's or Doctor of pharmacy degree (PharmaD) from an accredited institution. Active Pharmacist license in good standing. Minimum 5 years of experience in a pharmaceutical manufacturing or regulatory environment. Strong knowledge of GMP, regulatory compliance, and quality systems. Excellent organizational, communication, and leadership skills.
    $28k-44k yearly est.
  • Disaster Recovery Exercise Coordinator (Puerto Rico)

    RTX Corporation

    Santa Isabel, PR

    **Country:** United States of America ** Remote **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. **Security Clearance:** None/Not Required RTX Corporation is an Aerospace and Defense company that provides advanced systems and services for commercial, military and government customers worldwide. It comprises three industry-leading businesses - Collins Aerospace Systems, Pratt & Whitney, and Raytheon. Its 185,000 employees enable the company to operate at the edge of known science as they imagine and deliver solutions that push the boundaries in quantum physics, electric propulsion, directed energy, hypersonics, avionics and cybersecurity. The company, formed in 2020 through the combination of Raytheon Company and the United Technologies Corporation aerospace businesses, is headquartered in Arlington, VA. The following position is to join our RTX Enterprise Services team in Santa Isabel, Puerto Rico: Designs and facilitates disaster recovery exercises to validate enterprise readiness, identify gaps, and strengthen organizational response capabilities. **What You Will Do** + Plan and conduct tabletop, functional, and full-scale recovery exercises. + Coodinate lofistics, communications, and stakeholder participation. + Capture lessons learned and oversee corrective-action tracking. + Maintain exercise schedules and post-event reports. + This position will reference written work instructions for guidance with daily job activities. Work instructions are available in English only. + Travel 30%. **Qualifications You Must Have** + Typically requires a Bachelor's degree in Emergency Management, Information Technology, Computer Science, or related field, and minimum of 8 years prior relevant experience or an Advanced degree in a related field and a minimum 5 years experience. + 3+ years coordinating DR, continuity, or emergency exercises. + Strong organization, facilitation, and documentation skills. **Qualifications We Prefer** + Certified Exercise Practitioner (FEMA HSEEP) or equivalent. + DRII Certified Business Continuity Professional or ISO 22398 training. + Experience leading enterprise-scale or multi-site exercise. + Skilled in after-action reporting and improvement planning. **What We Offer** Whether you're just starting out on your career journey or are an experienced professional, we offer a robust total rewards package with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care. **Learn More & Apply Now!** **Location:** This position is remote. However, the successful candidate must live in Puerto Rico. **Please consider the following role type definition as you apply for this role:** **Remote:** This position is currently designated as remote. Employees who are working in Remote roles will work primarily offsite (from home). The employee may be expected to travel to the Santa Isabel site location as needed. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
    $38k-54k yearly est.
  • Quality Engineer II (3 openings)

    CIS International 4.6company rating

    Juncos, PR

    The Quality Engineer II will be responsible for supporting validation, risk management, and quality assurance activities in a regulated medical device manufacturing environment. This role requires expertise in validation protocols, statistical analysis, and regulatory compliance, with the ability to work cross-functionally with engineering, manufacturing, and quality teams to ensure product and process excellence. Key Responsibilities Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production. Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained. Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV. Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release. Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance. Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA). Lead complaint-handling activities in collaboration with operating unit members. Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations. Perform system administration and configuration of quality information technology systems. Prepare and maintain standard operating procedures (SOPs) for quality systems. Verify and document the effectiveness of CAPA and non-conformance resolutions. Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives. Report on validation activities to fulfill regulatory requirements. Minimum Requirements Bachelor's degree in Engineering (completed) Minimum 3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing). Experience with risk management documentation (pFMEAs). Experience in process validation and equipment qualification (excluding cleaning processes). Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory). Basic to intermediate statistical analysis skills, preferably with Minitab. Knowledge of defining validation strategies from design to manufacturing. Knowledge of Good Manufacturing Practices (GMP) and medical device regulations. Bilingual (English & Spanish - oral and written). Willingness to work 100% on-site. Preferred Qualifications (Nice to Have) Experience with design transfer activities and new product introduction projects. Experience investigating manufacturing events and supporting product disposition. Lean Six Sigma Green Belt Certification. Experience in defect/reject trend analysis. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project). Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR - ABRA Suite, Gallup Online Tool. Strong problem-solving and collaboration skills. Availability to work overtime and weekends when necessary. Work Methodology: Full time contract 100% on-site job in Medtronic-Juncos, PR 6 months of first contract with potential extensions based on performance and budget availability Administrative shift with availability to work non administrative hours or weekends
    $40k-50k yearly est.
  • Credentialing Specialists

    Armada Ltd. 3.9company rating

    Caguas, PR

    Job Description Type: Full Time Overtime Exempt: Yes Reports To: ARMADA HQ Travel Requirement: YES, nationwide to support onsite credentialing operations as mission needs require. Security Clearance Required: N/A *************CONTINGENT UPON AWARDING OF GOVERNMENT CONTRACT******** Credentialing Specialists will provide credentialing service and support to operate IRS credentialing sites utilizing the GSA scheduling tool to manage credentialing appointments, run reports through the USAccess system, and use credentialing equipment to conduct post issuance and enrollment activities. These duties and responsibilities include, but are not limited to the following: Duties & Responsibilities: The Credentialing Specialists shall: View, manage, and check daily appointments in time trade scheduling tool Credentialing Specialists shall perform enrollment and Issuance of Identification Cards to include PIV/Smart IDs, Access Cards, PAC Cards, issue and activate SmartID Cards, Perform Certificate Rekey, Pin Reset, and Card Update Credentialing Specialists shall perform card inventory and log cards on the Credential Inventory Tool (CIT) Store cards in a lockable container (file cabinet) Credentialing Specialists shall contact employees and contractors to schedule pick-up and activate SmartID Credentialing Specialists shall issue PAC Cards and Access Cards Issue Pocket Commission Credentials Collect SmartID Cards and PAC Cards; return terminated credentials to the Security Officer for destruction Credentialing Specialists shall keep a log of Cards issued and collected Perform Registrar and Activator duties as required Credentialing Specialists shall perform Card Custodian duties Credentialing Specialists shall mail SmartID Cards to Light Activation Kit Operators Applicant Communications regarding credential status Credentialing Specialists shall take photo, capture digital signatures, and assemble Pocket Commission inserts, and other ID Media duties as directed by ICAM Credentialing Specialists shall perform IRS credentialing functions and may be required to travel up to 40% of their annual work hours to support IRS credentialing and activation efforts. Short-term shiftwork to support the standard workday, night shift and weekend hours, shall be required Other duties as assigned. Knowledge, Skills, and Abilities (KSAs): Ability to complete required online credentialing training and maintain compliance with PIV-II SmartID credential requirements. Knowledge of ICAM and USAccess credentialing processes, including enrollment, activation, and verification procedures. Ability and willingness to travel nationwide to support onsite credentialing operations as mission needs require. Knowledge of credentialing hardware such as FCUs, MCUs, and LAKs. Knowledge of PII handling and federal credentialing policies. Skill in managing daily credential operations, workstations and equipment. Strong customer service and communication skills. Skill in preparing and submitting daily site reports. Strong attention to detail and documentation accuracy. Ability to follow federal credentialing standards and procedures. Minimum/General Experience: Experience with or ability to complete USAccess Registrar and Activator training or a comparable credentialing program. Experience preparing, reviewing, and submitting required reports and documentation in accordance with established procedures. Ability and willingness to travel nationwide to support onsite credentialing operations as mission needs require. Minimum Education: High School Diploma, or equivalent Disclaimer: The above information has been designed to indicate the general nature and level of work to be performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of the contractor assigned to this position. Applying: If you feel you have the knowledge, skills and abilities for this position visit our careers page at ****************** Special Notes: Relocation is not available for these jobs. ARMADA provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. ARMADA complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Must be able to successfully pass a background check, and pre-employment drug testing. Job offers are contingent upon results of background check and drug testing.
    $34k-49k yearly est.
  • Utilities Technician

    Flexible & Integrated Technical Services

    Juncos, PR

    For utility services in the manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Associate Degree with two (2) years of experience in industrial mechanics within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management skills. Shift: 12-hour rotational shift, and according to business needs. 5:00 PM - 5:00 AM 5:00 AM - 5:00 PM Experience in: Preventive maintenance HVAC, pumps, Utilities, and HEPA certification The Personality Part: If you have excellent communication skills and aren't afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of 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) Execute intermediate maintenance activities or operate and monitor plant support equipment, referring to complex issues or problems. Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for. Perform various "Housekeeping " activities (e.g., keeping work areas clean, cleaning equipment, etc.). Ensure that operational log paperwork, daily log files, and work order documentation are completed with accurate information. Provide a detailed training program to develop one's knowledge in the maintenance and operations field and other plant areas. Maintain an up-to-date cGMP training book. Develop, revise, and review related SOPs or job plans/work plans for work-related areas. Assist in the evaluation of the current maintenance procedures and recommend changes to optimize the maintenance program. Perform intermediate troubleshooting of utility, process, and HVAC-related equipment/ systems. Plan and schedule own work activities with operations staff to minimize impact on production activities. 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?
    $34k-45k yearly est. Auto-Apply
  • LL02-251022 C&Q Lead - Inspection Lines

    Validation & Engineering Group

    Gurabo, PR

    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: The C&Q Lead - Inspection Lines oversees and coordinates all Commissioning and Qualification activities for visual inspection systems used in sterile drug product operations, including both manual and automated inspection technologies. This role ensures equipment, control systems, and supporting utilities are qualified in compliance with regulatory standards (FDA, EMA, Annex 1) and ready for GMP use at site start-up. Key Responsibilities Project Leadership & Planning Lead end-to-end C&Q scope for automated and semi-automated inspection lines, including: Vision systems for vial, syringe, and cartridge inspection Conveyance and reject mechanisms Integration with MES / SCADA / Serialization systems Container closure integrity test (CCIT) systems Develop and maintain the Inspection C&Q Master Plan, aligning with the overall site Validation Master Plan. Coordinate activities across Engineering, QA Validation, Automation, and Manufacturing Operations. Establish and monitor C&Q milestones for inspection systems to meet project timelines and regulatory readiness. Commissioning & Qualification Execution Oversee preparation, review, and approval of URS, FAT/SAT, IOQ protocols, and summary reports. Ensure equipment and vision systems meet GAMP 5, 21 CFR Part 11, and data integrity standards. Manage vendor FAT/SAT and site integration testing; ensure punch-list closure. Supervise execution of C&Q protocols in accordance with ASTM E2500 and ISPE Baseline guides. Maintain traceability between design requirements and executed testing. Technical Oversight Serve as Subject Matter Expert (SME) for vision inspection and serialization systems. Review and approve: Vision and camera configuration documentation Control system design (PLC, HMI, SCADA, MES interfaces) CCIT and reject logic configuration Troubleshoot technical issues and support automation integration with packaging and filling operations. Compliance & Documentation Ensure C&Q documentation aligns with GMP, GDP, and corporate validation standards. Support Quality Assurance during audits and regulatory inspections. Ensure all deviations, CAPAs, and change controls related to C&Q are properly documented and closed. Maintain digital records in the validation platform (e.g., Kneat or ValGenesis). Collaboration & Leadership Work closely with Process Engineering, Packaging, and QA Validation to ensure seamless qualification and handover. Mentor junior C&Q engineers assigned to inspection or packaging areas. Participate in daily coordination and readiness meetings to track progress and resolve issues proactively. QualificationsEducation Bachelor's degree in Engineering (Mechanical, Electrical, Automation, or related field). Experience 8+ years of experience in Commissioning & Qualification for pharmaceutical or biotech facilities. 3+ years specific to automated visual inspection or packaging systems. Experience in aseptic operations and data integrity requirements (GAMP 5, 21 CFR Part 11). Strong understanding of Annex 1 and ISPE GPG: Visual Inspection of Parenterals. Technical Competencies Knowledge of camera systems, vision software, reject mechanisms, serialization, and MES connectivity. Proficient in using electronic validation tools such as Kneat or ValGenesis. Skilled in reviewing FAT/SAT documents, IOQ protocols, and risk assessments. Preferred Previous experience qualifying inspection lines from Syntegon, Antares, Brevetti, or Seidenader. Knowledge of CCIT methods (vacuum decay, laser headspace, or HVLD). Experience in greenfield or expansion projects for aseptic/sterile operations.
    $36k-63k yearly est.
  • Data Integrity Specialist

    Pharmeng Technology Americas

    Gurabo, PR

    PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. Data integrity specialists are responsible for ensuring that data is accurate and consistent across an organization. They commonly work with databases or other large pools of information, looking for errors or inconsistencies that may have been introduced during the collection, storage, or transmission process. Responsibilities Ensure the accuracy and completeness of data across multiple platforms through analysis, auditing, and reporting. Develop and maintain data integrity policies and procedures in alignment with organizational goals. Conduct regular audits of data to identify errors, discrepancies, or missing information. Investigate root causes of data issues and work with relevant teams to resolve them. Generate reports on data integrity findings for internal and external stakeholders. Keep abreast of new developments in data management and data integrity best practices. Train staff on data integrity procedures and policies Assist with the development and implementation of data governance framework. Monitor compliance with data integrity policies and procedures. Escalate non-compliance issues to senior management as needed. Maintain up-to-date knowledge of relevant laws, regulations, and industry best practices. Perform other duties as assigned. Required Skills and Qualifications Bachelor's degree in computer science, information technology, or related field 3-5 years professional experience working with Data Integrity Experience developing and implementing data quality control processes. Exceptional attention to detail and strong analytical skills Ability to work independently and as part of a team. Proficient in Microsoft Excel and Access
    $49k-65k yearly est. Auto-Apply
  • Calibration/ Metrology Technician - Caguas

    Mentor Technical Group 4.7company rating

    Caguas, PR

    Calibrates electronic test measuring equipment and signal generating equipment to conform to set standards. Tests, calibrates, adjusts, and maintains electromechanical, mechanical, optical, pneumatic, hydro mechanical, and pressure-type measuring and indicating instruments. Sets up calibration sequences, methods and procedures according to detailed specifications, blueprints, drawings, and requirements. Disassembles, cleans, repairs, and replaces defective parts of test equipment such as pressure gauges and tension meters. May monitor and verify quality in accordance with statistical process or other control procedures. Position Responsibilities • Performs all necessary transactions in the electronic system in order to ensure integrity of calibration/inspection data. • Writes, modifies, and maintains procedures used for calibration activities. • Troubleshoots and repairs equipment to restore within acceptable limits. • Inspects fixtures, tooling and overlays as per the established procedures. • Supports product transfers and new implementations. • Assists in the investigations of quality issues and non-conforming situations as required. • Prepares and presents trend data pertaining to the calibration area during monthly Quality Review meetings. • Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc. Performs other position related duties as assigned. Minimum Education Associate Degree or 60 undergraduate approved credits as equivalent Basic Qualifications Background • Educational: Industrial Technology, Instrumentation, Electronics or related field • Experience: o Associate Level: 0 Years with Diploma/ Degree o Intermediate Level: 3+ Years with Diploma/ Degree or 0 Years with Advanced Diploma/ Degree o Senior Level: 5+ Years with Diploma/ Degree or 3+ Years with Advanced Diploma/ Degree o Principal Level: 7+ Years with Diploma/ Degree or 5+ Years with Advanced Diploma/ Degree o Senior Principal Level: 10+ Years with Diploma/ Degree or 7+ Years with Advanced Diploma/ Degree • Exposure to manufacturing environment Skills • Analytical Thinking • Problem Solving • Interpersonal Relations • Quality and Results Oriented • Computer Literate • Basic oral and written communication skills in Spanish and English Desired/ Preferred Qualifications Background • Experience in medical device, pharmaceutical, or electronic industry • Ability to understand and apply industrial standards in metrology and calibration for temperature, humidity, pressure/ vacuum, electronic and dimensional equipment • Knowledge of standards and regulatory requirements applicable to calibration activities • Certified Calibration Technician from approved college • Experience in the development of calibration/inspection work instructions Skills • Teamwork • Communications • Continues Improvement • Project Management The candidates need to have experience and expertise in the following skills; • Vision systems routines configurations in CMM and Smart Scopes “OGPs”. • Process and Software Validations. • GDT Knowledge. • Expert in drawings specifications readings and interpretation. • Available to work overtime and weekends shifts. • English and Spanish Language. • Available to travel. Quality Responsibilities •Reports any observed or informed process and/or product non-conformities to the Supervisor. •Finds resolution of Quality Situations at the area of responsibility. •Reports any complaint regarding a Medtronic product to the Supervisor. •Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. •Participate in the development of EHS improvement projects. •Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Engineers in Projects: (if apply) •Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the cost/benefit ratio and minimize the EHS impacts and risks. •Ensure that EHS performance indicators are included in the selection process of contractors. •Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors. •Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks. •Maintain current knowledge of the potential EHS aspects and risks of new projects. 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.
    $79k-104k yearly est. Auto-Apply
  • Manufacturing Engineer I

    Pharma-Bio Serv, Inc. 4.3company rating

    Juncos, PR

    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 East Region sector is looking to hire a Manufacturing Engineer. Requirements: * Bachelor's degree in Engineering is required * 2-3yrs of engineering experience in Medical Device industry. * Problem Solving knowledge (Yellow or Green Belt knowledge). * Experience in improvement projects.
    $56k-67k yearly est.
  • Commissioning & Qualification Lead - Upstream & Downstream Process Equipment LL05-250822

    Validation & Engineering Group

    Gurabo, PR

    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: CQV Lead - Upstream & Downstream Biotech Process Equipment The CQV Lead will be responsible for overseeing all commissioning, qualification, and validation activities related to upstream and downstream process equipment in a biotech GMP manufacturing facility. This includes strategic planning, resource coordination, protocol development, execution oversight, and stakeholder engagement across the CQV lifecycle. The role requires a strong technical background in cell culture and purification systems, as well as leadership experience in cross-functional environments supporting project delivery, regulatory compliance, and schedule milestones. Key Responsibilities: Leadership & Project Management Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule and quality standards. Manage CQV engineers and contractors; assign responsibilities and oversee protocol development and execution activities. Represent CQV function in cross-functional meetings with QA, Manufacturing, Automation, Process Engineering, and Project Controls. Develop CQV strategy, work plans, and schedules in alignment with URS, risk assessments, and cGMP expectations. Support the resolution of deviations, non-conformances, and issues identified during commissioning and qualification. Documentation & Execution Oversight Oversee the preparation and approval of commissioning plans, IQ/OQ/PQ protocols, risk assessments, and summary reports. Ensure traceability from URS to qualification deliverables (RTM). Approve system walkdowns, punchlist resolutions, and impact assessments. Lead or support FAT/SAT coordination and vendor engagements. Compliance & Quality Assurance Ensure CQV activities are conducted in accordance with FDA, EMA, ICH Q8-Q10, ISPE Baseline Guide Vol. 5, and ASTM E2500. Collaborate with QA to ensure timely approvals of protocols and reports. Ensure all validation deliverables support readiness for regulatory inspections and PPQ readiness. Equipment in Scope: Upstream Systems: Bioreactors (single-use and stainless steel) Media preparation systems and skids Cell culture support equipment (incubators, mixing tanks) Control systems for pH, DO, temperature, agitation Seed train and expansion systems Downstream Systems: Chromatography systems (Protein A, IEX, etc.) Tangential flow filtration (TFF) skids Virus filtration/inactivation systems Centrifuges and depth filtration units Bulk hold tanks and transfer skids CIP/SIP systems interfacing with both upstream and downstream trains Qualifications: Bachelor's or Master's degree in Engineering, Biotechnology, or related Life Sciences field. Minimum 7-10 years of CQV experience in GMP biopharmaceutical manufacturing. Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects. Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes. In-depth understanding of validation lifecycle and GMP documentation. Excellent communication, coordination, and problem-solving skills. Preferred Experience: Use of electronic validation platforms (e.g., Kneat, Valgenesis). Familiarity with DeltaV, Rockwell, or Siemens PCS automation. Previous experience on large-scale biotech capital projects (greenfield/brownfield). Experience interfacing with Quality Assurance and regulatory auditors.
    $25k-44k yearly est.
  • Industrial Engineering Internship

    Corteva Agriscience 3.7company rating

    Salinas, PR

    We're looking for a motivated Industrial Engineering student to join our team as an intern. This role offers hands-on experience in a fast-paced agricultural operations environment, with a focus on process improvement and workflow optimization. **Key Responsibilities:** + Support ongoing evaluations of processing workflows to identify bottlenecks and areas for improvement. + Assist in layout reviews, and efficiency assessments across seed processing stations. + Collect and analyze operational data to support decision-making and continuous improvement initiatives. + Collaborate with team members to implement small-scale trials and monitor results. + Document findings and present recommendations to supervisors and team leaders. **Preferred Qualifications:** + Must be a **sophomore or higher** pursuing a degree in Industrial Engineering. + Must have a minimum GPA of 3.00 or higher. + Strong analytical and problem-solving skills. + Comfortable working with data and basic statistical tools. + Good communication and teamwork abilities. + Interest in agricultural operations or manufacturing environments is a plus. **Learning Opportunities:** + Exposure to real-world industrial engineering applications in seed processing. + Experience with lean principles, process mapping, and operational metrics. + Opportunity to contribute to impactful projects that improve efficiency and quality. Corteva Agriscience is an equal opportunity employer. We are committed to boldly embracing the power of inclusion, diversity, and equity to enrich the lives of our employees and strengthen the performance of our company, while advancing equity in agriculture. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. Discrimination, harassment and retaliation are inconsistent with our values and will not be tolerated. If you require a reasonable accommodation to search or apply for a position, please visit:Accessibility Page for Contact Information For US Applicants: See the 'Equal Employment Opportunity is the Law' poster. To all recruitment agencies: Corteva does not accept unsolicited third party resumes and is not responsible for any fees related to unsolicited resumes.
    $35k-38k yearly est.
  • Project Coordinator IV

    Mg Staffing Group

    Juncos, PR

    Project Coordinator will be responsible for supporting various projects, managing procurement processes, coordinating with different departments, and leading community activities. The ideal candidate will have strong communication and organizational skills, as well as the ability to adapt to changing project needs. Responsibilities: Create and place purchase orders. Support special projects. Create payment requests and support accounts payable for Puerto Rico activities. Create and manage supplier relationships. Schedule transportation and other travel arrangements. Provide support to IT, Facilities, and HR functions. Lead and coordinate activities with the Communities. Perform other ad hoc activities as required. Requirements Minimum of 6 years of experience in a similar role or equivalent. Fluent in English, both speaking and writing. Dedicated and detail\-oriente. Willing to work 100% On\-site. Skills: Communication skills: Interact effectively with project managers, sponsors, stakeholders, and project teams. Problem\-solving skills: Quickly develop solutions and strategies for various issues and challenges. Change management skills: Adapt to changes in project plans and manage variables effectively. Organizational skills: Exhibit strong time management, delegation, planning, and decision\-making abilities. "}}],"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":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Project Coordinator IV","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015881104","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26niadiq1S.pW3A5GdykbRDg\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}
    $28k-53k yearly est.
  • Disaster Recovery Liaison (Puerto Rico)

    RTX Corporation

    Santa Isabel, PR

    **Country:** United States of America ** Remote **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. **Security Clearance:** None/Not Required RTX Corporation is an Aerospace and Defense company that provides advanced systems and services for commercial, military and government customers worldwide. It comprises three industry-leading businesses - Collins Aerospace Systems, Pratt & Whitney, and Raytheon. Its 185,000 employees enable the company to operate at the edge of known science as they imagine and deliver solutions that push the boundaries in quantum physics, electric propulsion, directed energy, hypersonics, avionics and cybersecurity. The company, formed in 2020 through the combination of Raytheon Company and the United Technologies Corporation aerospace businesses, is headquartered in Arlington, VA. The following position is to join our RTX Enterprise Services team in Santa Isabel, Puerto Rico: **What You Will Do** + Act as primary contact for BU recovery coordination. + Support plan certification, testing, and evidence collection. + Facilitate communication between technical and business teams. + Report readiness status and escalate risks to governance leadership. + This position will reference written work instructions for guidance with daily job activities. Work instructions are available in English only. **Qualifications You Must Have** + Typically requires a Bachelor's degree in Business, IT, or Operations Management and minimum of 8 years prior relevant experience or an Advanced degree in a related field and a minimum 5 years experience. + 3-5 years in stakeholder engagement or continuity coordination. + Strong communication and organization skills. **Qualifications We Prefer** + ABCP, CBCP, or ISO 22301 Practitioner certification. + Training in Crisis Communication or Incident Management. + Experience working across global or regulated operations. **What We Offer** Whether you're just starting out on your career journey or are an experienced professional, we offer a robust total rewards package with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care. **Learn More & Apply Now!** **Location:** This position is remote. However, the successful candidate must live in Puerto Rico. **Please consider the following role type definition as you apply for this role:** **Remote:** This position is currently designated as remote. Employees who are working in Remote roles will work primarily offsite (from home). The employee may be expected to travel to the Santa Isabel site location as needed. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
    $38k-54k yearly est.
  • Jt749 - Process Engineer II

    Quality Consulting Group

    Juncos, PR

    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: 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 4 years of relevant experience Proficient in validation process, CSV, PV Proficient in Troubleshooting, Equipment Setups Proficient in document management Change control of Medical Devices Equipment Commissioning / Qualification Process Validation 4. Computer System Validation (CSV) Manufacturing, Packaging and Laboratory Equipment Technical experience (Trouble shooting) or any similar experience or background Quality / Process Control / Assurance of Medical Device 1st shift (8am to 5pm) 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.
    $69k-91k yearly est. Auto-Apply

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Recently added salaries for people working in Arroyo, PR

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Full time jobs in Arroyo, PR

Top employers

Hospital Lafayette

3 %

Instituto Psicomédico Lafayette

2 %

Puerto Rico Army National Guard

2 %

Del Carmen Pharmacy

2 %

Top 10 companies in Arroyo, PR

  1. Stryker
  2. Hospital Lafayette
  3. Dewey University
  4. Instituto Psicomédico Lafayette
  5. United States Army Corps of Engineers
  6. Puerto Rico Army National Guard
  7. Pueblo
  8. Del Carmen Pharmacy
  9. Municipality of Arroyo
  10. Lafayette Hospital