Quality assurance analyst jobs in Guaynabo, PR

Job Description We are seeking a motivated and detail-oriented Pentester Junior to join our cybersecurity team. The ideal candidate will support penetration testing activities to identify vulnerabilities in systems, networks, and applications. This role involves learning and applying ethical hacking techniques, documenting findings, and collaborating with senior security staff to enhance the organization's overall security posture. The position is ideal for individuals beginning their cybersecurity career who demonstrate strong analytical thinking, curiosity, and a commitment to continuous learning. Responsabilities and Duties: Perform penetration testing activities under supervision, including vulnerability identification, exploitation, and documentation. Stay up-to-date on emerging cybersecurity threats, vulnerabilities, and attack techniques. Assist in researching and developing new penetration testing methodologies, scripts, and tools. Conduct remote or onsite penetration tests to assess system and network security. Simulate security breaches to evaluate the effectiveness of existing security controls. Prepare detailed reports outlining findings, risk levels, and recommended remediation strategies. Present findings and risks to management and relevant stakeholders in a clear and professional manner. Collaborate with the security team to improve organizational security posture. Evaluate and communicate the business impact of identified vulnerabilities. Maintain a professional and ethical approach while performing security assessments. Qualifications: Bachelor's degree in cybersecurity, information technology, computer science, or a related field. No prior penetration testing experience required. Strong understanding of cybersecurity principles, defensive strategies, and attack concepts. Familiarity with common security tools and technologies (e.g., Nmap, Burp Suite, Kali Linux). Basic knowledge of computer networks, protocols, and operating systems. Excellent problem-solving and analytical skills. Strong verbal and written communication abilities. Ability to work independently and collaboratively within a team. Ability to manage multiple tasks, work under pressure, and meet established deadlines. Security certifications such as Security+, CEH, OSCP are preferred but not required. We are an Equal Opportunity Employer (EOE/M/F/V/D). Job Type: Full-time Pay: 25,000.00-35,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance Work Location: In person M-F 8AM-5PM

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing. As part of the role will support project implementation for the site in all phases ensuring compliance with requirements and regulations. Support and oversight as Quality Unit for qualifications and all related documentation. Responsibilities: Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements: * Participating in qualification strategies, change control evaluations, deviation assessments, periodic quality evaluations, procedure management, and documentation retention * Fulfill individual training plans, act as a quality procedure instructor and mentor, actively participate in Flow Team activities, and attend departmental meetings * Monitoring pest control and facility maintenance, supporting Lean implementation, evaluating validations and changes related to utilities, equipment, and facilities, and ensuring regulatory plan approvals * Ensures compliance with data integrity per 21 CFR Part 11, computerized system validation policies, and handles controlled substances according to legal and company requirements, including reporting deviations and illicit activities Basic Requirements: * Bachelor's degree in Engineering (Chemical, Electrical or Mechanical) * Minimum of 3 years of experience in facilities, equipment, utilities and FDA regulated environment. * PE or EIT, preferred Additional Skills/Preferences: * Bilingual (English/Spanish) with strong written and oral communication skills * Strong leadership and organizational skills * Sound judgment * Teamwork oriented; ability to work cross functionally * Able to manage multiple project objectives or assignments * Strong customer service focus Additional Information: * Able to work extended hours as applicable to support business needs * Located at Carolina, PR * This position is not permanent. It is for a fixed term position up to a maximum of 1 year. * * Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $52,500 - $154,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Monitors and tracks all sources of quality detractors utilizing the service database and complaint database. Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations. Develops solutions to database problems of moderate scope and complexity. Writes and assists others in writing standard operating procedures. Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams. Provides advanced technical assistance in the use of information mapping technology. Provides support to product review and release functions. Generates moderately complex statistical summaries. Provides support to good manufacturing practice auditing. Requirements Minimum 2 years of experience with Investigations and complaints. Work experience with quality system in the pharma industry is acceptable. Bachelor's degree in Science completed. Willing to work 100% on\-site Gurabo. "}}],"is Mobile":false,"iframe":"true","job Type":"Contract","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":"Gurabo"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00778"}],"header Name":"Analyst 2 \- Quality Assurance","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016530006","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26rdEozDrUdYhKge.sh YqcHw\-&embedsource=Google","location":"Gurabo","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

Arival Bank International Corp. is a US-based digital bank licensed and regulated by OCIF. After obtaining our US-based banking license at the beginning of 2021, we officially went live in June 2021 and have onboarded 650+ B2B customers from over 60+ countries. Equipped with forward-thinking compliance, Arival is on a mission to become the go-to digital bank for corporate and institutional clients all over the world. We're actively growing our international team with offices in Puerto Rico, Europe, and Singapore, with over 60+ employees, and building many departments from the ground up. EVERYDAY TASKS:Manual and auto testing of company's products. Reviewing functional requirements, technical design documents and providing meaningful feedback. Writing and supporting test documentation (test plans, test cases and checklists). Identifying, troubleshooting, and tracking bugs to resolution. Supporting existing products and improving them. Working closely with our product team. JOB REQUIREMENTS:Knowledge of software testing theory. Understanding the software development life cycle. Understanding the architecture of client-server and web applications. Experience in functional, API, WEB (or mobile) applications testing. Understanding frontend and backend testing approaches and the ability to apply them. Ability to write test documentation. Ability to analyze business and functional requirements. Fluency in Scrum and Agile methodologies. Experience troubleshooting and debugging production issues. 3+ years of commercial development experience. Solid understanding of the whole web stack and how all the pieces fit together (front-end, server-side, database, network layer, etc. ). Native to the startup world, used to its dynamic, fast-paced and demanding environment. Deep knowledge and understanding of fintech. DESIRED QUALIFICATIONS:Upper Middle or Senior level. Bachelor's degree in relevant field. Master's degree and/or relevant certifications are a plus. Digital banking and/or fintech experience is preferred. Strong knowledge of banking operations processes. A creative approach, with the ability to anticipate challenges and develop innovative solutions. Ability to confidently collaborate with a range of colleagues and departments across our organization as well as working solo. Strong communicative and presentation skills. Ability to identify key themes and communicate relevant insights that drive decision making Good communication skills, written and verbal with the ability to simplify data and build recommendations based on insights gathered. Willingness to work across different time zones with global and regional teams BENEFITS:Join our international team of visionaries in startup attire. Enjoy a highly diverse and international culture. An opportunity to build future, freedom to work anywhere you want. Fair pay, no matter where you live along with a competitive benefits package. Health, dental, and vision insurance. Disability benefits. 401(k) plan with corporate matching. Computer setup of your choice. Generous paid time off to relax and recharge. Opportunity to work in a growing mission-driven startup.

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 Specialist Smoke Testing / Airflow Visualization Overview The CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing. Key Responsibilities * Plan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments. * Set up and qualify smoke/fog generation equipment, lighting, and video recording systems. * Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps. * Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems. * Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence. * Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues. * Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance. * Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500. * Support regulatory inspection readiness and provide airflow-related technical responses. Required Qualifications * Bachelors in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field. * 5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning. * Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification. * Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS. * Ability to interpret airflow patterns and provide engineering recommendations. Preferred Skills * Experience with particle counters, differential pressure monitoring, BMS/EMS systems. * Experience qualifying sterile filling lines or aseptic equipment. * Knowledge of HVAC balancing, cleanroom design, and environmental controls.

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. Functions: - Review and approve product MPs. - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team. - Approve Environmental Characterization reports. - Release of sanitary utility systems. - Approve planned incidents. - Represent QA on NPI team. - Lead investigations. - Lead site audits. - Own site quality program procedures. - Designee for QA manager on local CCRB. - Review Risk Assessments. - Support Automation activities. - Support facilities and environmental programs. - Review and approve Work Orders. - Review and approve EMS/BMS alarms. - Approve NC investigations and CAPA records. - Approve change controls. - Provide lot disposition and authorize lots for shipment. Education: -Masters + 2 years of directly related experience. -Bachelors + 4 years of directly related experience. Preferred Qualifications: Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non conformances). Skills: - Project management skills. - Strong organizational skills, including ability to follow assignments through to completion. - Initiate and lead cross functional teams. - Enhanced skills in leading, influencing and negotiating. - 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, QA, QAL, 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. - Strong skill in working independently and to effectively interact with various levels. - Advanced data trending and evaluation. - Ability to evaluate compliance issues. - Demonstrate the Amgen Values/Leadership Practices. Work Methodology: 100% On-site 36 months (1st Contract) 3rd (10:00 pm-6:30 am) and Non- Standard Shift (weekends and overtime may also be required). Professional Service Contract

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

Every day at Disney Cruise Line we take pride in bringing the magic of Disney to life. We find joy in creating cherished memories and form genuine connections with our guests. We hold each other to the highest degree and always act responsibly while ensuring the safety of fellow crew and guests. United by our Disney values, we work toward excellence in all we do. As a part of our team, you can live and work in a diverse and inclusive environment amidst a professional and supportive community. If you are ready to create unforgettable experiences and grow as a person and as a professional, apply today. As Automation Engineer you will be responsible for maintenance and troubleshooting of electrical and electronic systems in the machinery spaces, entertainment equipment, bridge equipment and hotel areas. Level: 2.5 stripes Officer **Responsibilities :** + Responsible to properly complete the monthly maintenance routines for equipment under their control, and to report all completed work on the AMOS system. + All electronics systems relating to the operation, control, monitoring safety and surveillance of the mechanical, electrical, hydraulic, pneumatic and thermal equipment contained within the main machinery spaces + Responsible for ship's communication systems, bridge navigation equipment. + Telephone exchange + Security alarm systems + CCTV Systems + Fire Protection Systems + Maintenance (AMOS Monthly routines and unscheduled call outs) of mechanical, electrical, electronic equipment in Entertainment areas, including partnering with the Entertainment Technical team for support and equipment familiarization. + Performs Emergency duties as specified in the ships Assembly Plan + Uphold the general safety management responsibilities in areas and operations under their control. **Basic Qualifications :** + Electro-technical Officer Certificate of Competency + 2+ years' shipboard experience as senior Electro-technical Officer on cruise vessels + Excellent communication skills, including fluent written and spoken English + Enthusiasm about guiding other team members + Flexibility and a cool head in dynamic, ever-evolving environments **Additional Information :** This is a **SHIPBOARD** role. Applicants must: + Be genuinely interested in a career at sea and willing to live and work onboard a Disney Cruise Line vessel + Be committed to the position you are applying for at least 2-3 contracts before a transfer or promotion + Be willing to follow and perform safety role, emergency duties and/or associated responsibilities as specified in the ship Assembly Plan + Be willing and able to uphold the general safety management responsibilities specified in the Safety Management System in areas and operations under their control + Be willing to follow and embrace United States Public Health requirements and guidelines as well as Environmentality requirements and Company practices + Be willing to be appreciative of working and living in a multi-cultural environment + Be comfortable living in a confined space with strict rules and regulations + Adhere to a structured lifestyle, personally and professionally Your Responsibilities: + Have a valid passport and C1/D Seaman's visa (DCL will provide you with documents to obtain this) + Complete a pre-employment medical + Obtain a criminal background check + Bring approved work shoes ** _Disney Cruise Line_ is a drug-free workplace. All new hires are required to undergo drug/alcohol testing within the first week onboard and throughout their contracts. Failure to pass the drug/alcohol testing will result in immediate termination. \#DCLMTO **Job ID:** 1249122BR **Location:** United States **Job Posting Company:** "Disney Cruise Line" The Walt Disney Company and its Affiliated Companies are Equal Employment Opportunity employers and welcome all job seekers including individuals with disabilities and veterans with disabilities. If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Candidate.Accommodations@Disney.com with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website ************************ to learn more about our services and solutions! Job Description We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection, warehouse floor audits, and deviation management. The ideal candidate will bring technical expertise, digital fluency, and a strong understanding of regulated environments. Primary Focus Areas • Perform sampling and inspection of incoming materials and components. • Conduct quality audits of warehouse floor operations to ensure compliance with SOPs and GMP standards. • Initiate, investigate, and approve quality deviations (non-conformances) in coordination with cross-functional teams. • Utilize Smartsheet, Power BI, SAP, and Generative AI tools to manage quality data, reporting, and workflows. Additional Responsibilities • Review and approve Master Production Records (MPs) and process validation protocols/reports. • Represent QA on New Product Introduction (NPI) teams and incident triage groups. • Approve Environmental Characterization reports and release sanitary utility systems. • Lead investigations and site audits; own site-level quality program procedures. • Act as designer for QA Manager on local Change Control Review Board (CCRB). • Review risk assessments, work orders, EMS/BMS alarms, and planned incidents. • Approve NC investigations, CAPA records, and change controls. • Provide lot disposition and authorize product lots for shipment. • Support automation, facilities, and environmental compliance programs. Qualifications Education in a relevant scientific or engineering discipline: -Doctorate or Masters + 2 years of directly related experience or -Bachelors + 4 years of directly related experience Shift - Available for 3rd shit and Non-Standard Shift. Additional Information All your information will be kept confidential according to EEO guidelines.

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Requirements: Supply Chain Incoming sampling and inspection Quality audit of warehouse floor operations Proficient in Smartsheet, Generative AI, Power BI, SAP Initiating and approving Quality deviations (nonconformances) Responsibilities: Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Education: Doctorate or master's and 2 years of directly related experience; bachelor's and 4 years of directly related experience.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Responsibilities: Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Shift: 3rd Shift/Non-Standard Shift Location: Juncos, PR Education: Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Preferred Qualifications: Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non-conformances) Skills: Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating. 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, QA, QAL, 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. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Values/Leadership Practices. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for a Automation Engineer for its Puerto Rico office. Responsibilities/Essential Functions: Support automation and control systems for 24/7 operations. Develop, update, and test control system software and hardware. Install and coordinate automation equipment and software, including working with vendors. Troubleshoot control system issues and implement solutions. Provide technical support to automation technicians. Identify customer needs and address concerns about control systems. Monitor system performance, analyze trends, and define action plans. Evaluate automation systems to prevent safety, quality, or downtime risks. Lead investigations and implement corrective actions. Create and manage change controls, including technical assessments and cost estimates. Develop, review, and approve CSV documentation. Ensure validation and compliance with policies, quality standards, and EHS regulations. Communicate activities, priorities, and updates to teams and stakeholders. Participate in meetings and help drive key site initiatives. Understand how process, equipment, and control system changes affect automation. Requirements: Bachelor's degree in engineering (Electrical, Chemical, Computer, Mechanical, or Industrial). 3-5 years supporting pharmaceutical operations Availability to support a 24/7 operation. Desired Hard Skill Sets: Strong DeltaV programming skills (especially batch processes). Experience with computer systems validation (CSV) in regulated/GMP environments. Desired Soft Skills: Strong problem-solving, communication, leadership, and teamwork skills. Ability to manage multiple projects and adapt quickly. Deals well with uncertainty and pressure. Works well with others, within a team and takes accountability. Result driven and self-motivated. Organized, with strong computer literacy such as MS Project, Excel, etc. Fully fluent in English and Spanish.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. * Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. * Defines appropriate measures to ensure product quality. * Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. * Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. * Reviews software systems design, change specifications, and plans against contractual and/or process requirements. * Reviews include applicable specifications, materials, tools, techniques, and methodologies. * Provides or directs verification and validation of software system requirements, traceability, and testability. Shift: 1st and 2nd Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Preferred Qualifications: * Automation/ Controls / Programming hands on experience * CAPA/ Investigations/ Root Cause Analyses/Technical Writing * Computer Software validations/GAMP knowledge - hands on experience * Knowledge in Medical Devices regulations * Years' Experience Required: min.7 yrs on field (quality - excluding experience laboratory micro/chemistry ) or engineering or programming Must have: * Experience with Risk management documentation: pFMEAs * Basic knowledge in PLC, general programming, Source Code Review * Basic knowledge in Root Cause Analysis * Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) * Engineering degree: Mechanical, Electric * al or Computer preferred * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Knowledge in GAMP Skills: * Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . * Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . * May manage large projects or processes that span outside of immediate job area. * Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. * Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. * Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. * Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. * Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. * Defines appropriate measures to ensure product quality. * Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. * Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. * Reviews software systems design, change specifications, and plans against contractual and/or process requirements. * Reviews include applicable specifications, materials, tools, techniques, and methodologies. * Provides or directs verification and validation of software system requirements, traceability, and testability. Shift: 1st and 2nd Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Preferred Qualifications: * Automation/ Controls / Programming hands on experience * CAPA/ Investigations/ Root Cause Analyses/Technical Writing * Computer Software validations/GAMP knowledge - hands on experience * Knowledge in Medical Devices regulations * Years' Experience Required: min.7 yrs on field (quality - excluding experience laboratory micro/chemistry ) or engineering or programming Must have: * Experience with Risk management documentation: pFMEAs * Basic knowledge in PLC, general programming, Source Code Review * Basic knowledge in Root Cause Analysis * Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) * Engineering degree: Mechanical, Electric * al or Computer preferred * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Knowledge in GAMP Skills: * Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . * Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . * May manage large projects or processes that span outside of immediate job area. * Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. * Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. * Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. * Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

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 standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, changes specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Provides or directs verification and validation of software system requirements, traceability, and testability. Qualifications: Bachelor's degree in Engineering: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Minimum of 7 years of experience on field (quality - excluding experience laboratory micro/chemistry) or engineering or programming Experience with Risk management documentation: pFMEAs Basic knowledge in PLC, general programming, Source Code Review (e.g. Automation/ Controls / Programming hands on experience) Computer Software validations/GAMP knowledge - hands on experience Basic knowledge in Root Cause Analysis CAPA/ Investigations/ Root Cause Analyses/Technical Writing Basic knowledge in designing validation strategies (e.g. requirements flow down from design to manufacturing) Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Knowledge in Medical Devices regulations Knowledge in GAMP Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends. 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.

For Automation services in the Manufacturing and Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in engineering, Computer Science, Information Systems, or related field, and at least five (5) years of experience in pharmaceutical operations or manufacturing process. Bilingual: Spanish and English (verbal/ written) Shift: Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary. Experience in: Process automation in a pharmaceutical environment Computerized systems validation. CMMS & MES Systems: Experience with CMMS platforms (Maximo preferred) and Manufacturing Execution Systems (Syncade) for production tracking and maintenance management. Process Control & SCADA Systems: Knowledge and hands-on experience with industrial automation platforms including Siemens systems, Wonderware SCADA software, Factory Talk Batch, and OSI Soft AVEVA PI System for real-time data acquisition and historian capabilities. Enterprise IT Systems: Familiarity with virtualization technologies (VMWare vSphere) and relational database management (Microsoft SQL Database) to support manufacturing IT infrastructure. The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Manufacturing and Utilities Areas. Provides subject matter expertise in IT/Automation during installation, configuration, integration, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems in Manufacturing and Utilities Areas (systems include and not limited to PLCs, HMI, Delta V, Factory Talk, SCADA, DCS/BAS, communication interfaces, networking, printers, report engines, databases and MES system). Perform software or hardware changes to automation and computerized systems by developing analysis, recommending improvements to existing processes through the use of state-of-the-art computer technology. Participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology. Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) on operational and/or project activities, including providing progress updates on assigned tasks or assessments as needed. Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing and Utilities Areas. These systems include (not limited to), PLCs, SCADA, and Fourth generation languages for interfaces and report development. Provides user training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation. Reviews and test programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment. Review and evaluate proposed design changes to ensure alignment with client's requirements, cGMP, and data integrity best practices. Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments. Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems. Provides project status using project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers. Support the standards or strategy definition for software automation, system integration, minimum requirements for plant automation through analysis and design/re-design of current systems and processes. Develops and/or reviews automation and computerized system related procedures such as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery. Contacts hardware or software vendors (if applicable) to report or address problems. Coordinate and implement vendor recommendations. Assures reported problems are solved by implementing corrective actions like (but not limited) user retraining, changes to existing SOPs, applying software fixes or hardware fixes, Information Resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures. Completes CAPAs, standalone actions, assessments required as part of Quality Systems and/or Reliability program related to automation and computerized systems. Assist in the management of Capital Appropriation Requests (CAR's), and timeline of process automation projects and implementation and support Process Automation initiatives. Provides necessary support for Data Integrity and Cyber Security program and initiatives Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes. WHO WE ARE: We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical 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: CQV Specialist - Smoke Testing / Airflow Visualization Overview The CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing. Key Responsibilities Plan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments. Set up and qualify smoke/fog generation equipment, lighting, and video recording systems. Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps. Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems. Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence. Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues. Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance. Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500. Support regulatory inspection readiness and provide airflow-related technical responses. Required Qualifications Bachelor's in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field. 5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning. Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification. Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS. Ability to interpret airflow patterns and provide engineering recommendations. Preferred Skills Experience with particle counters, differential pressure monitoring, BMS/EMS systems. Experience qualifying sterile filling lines or aseptic equipment. Knowledge of HVAC balancing, cleanroom design, and environmental controls.

Responsibilities may include the following and other duties may be assigned: Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Define and implement appropriate measures to ensure product quality. Review software systems design, change specifications, and project plans against contractual and regulatory requirements. Ensure compliance with applicable specifications, tools, techniques, and methodologies. Provide or direct verification and validation of software system requirements, traceability, and testability. Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations. Represent the organization as primary contact for projects/initiatives, communicating with internal and external stakeholders. Provide mentorship, coaching, and training to other professionals within the team. Experience Requirements: Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro/chemistry experience). Advanced degree accepted with minimum 5 years of relevant experience. Automation / Controls / Programming hands-on experience CAPA, investigations, root cause analysis, and technical writing Computer software validations and GAMP knowledge - hands-on experience (Additional) Strong knowledge in medical devices regulations Experience with risk management documentation (PFMEAs) Experience designing validation strategies (e.g., requirements flow down from design to manufacturing) Perform and/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes) Knowledge of medical device regulations and GAMP standards Education Requirement: Bachelor's degree in Engineering (Mechanical, Electrical, or Computer/Software preferred). Technical Skills (Must Have) Investigation and root cause analysis skills Technical writing knowledge Strong organizational and communication skills Process validation and computer software validation knowledge Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports Experience in medical devices manufacturing Interpersonal skills to support product disposition investigations (PFMEA, atypical events) Automated source code management Computer software programming (including embedded software programming) Development of control plans and PFMEA Additional Technical Areas (Hands-On/Knowledge Required) Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting Vision Systems Instrumentation: overview and application Control Systems Data Structure & Sources Data Analysis Tools: SQL, Python, R Data Management Databases: data extraction, transformation, loading, database creation/maintenance, query overview (SQL/Non-SQL) Programming: Assembly (C), Object-Oriented Programming (Python, Java), error handling, abstract data types GUI/HMI Design: FactoryTalk, RSView Communication Networks Operating Systems FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022) Nice to Have Additional investigation and root cause analysis expertise Work Methodology: Full time contract 100% on-site job in Medtronic- Juncos, PR First contract until August 2026 based to performance and budget availability. Willing to work 1st or 2nd shift

Responsibilities may include the following and other duties may be assigned: Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Define and implement appropriate measures to ensure product quality. Review software systems design, change specifications, and project plans against contractual and regulatory requirements. Ensure compliance with applicable specifications, tools, techniques, and methodologies. Provide or direct verification and validation of software system requirements, traceability, and testability. Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations. Represent the organization as primary contact for projects\/initiatives, communicating with internal and external stakeholders. Provide mentorship, coaching, and training to other professionals within the team. Requirements Experience Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro\/chemistry experience). Advanced degree accepted with minimum 5 years of relevant experience. Automation \/ Controls \/ Programming hands\-on experience CAPA, investigations, root cause analysis, and technical writing Computer software validations and GAMP knowledge - hands\-on experience (Additional) Strong knowledge in medical devices regulations Experience with risk management documentation (PFMEAs) Experience designing validation strategies (e.g., requirements flow down from design to manufacturing) Perform and\/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes) Knowledge of medical device regulations and GAMP standards Education Bachelor's degree in Engineering (Mechanical, Electrical, or Computer\/Software preferred). Technical Skills Must Have Investigation and root cause analysis skills Technical writing knowledge Strong organizational and communication skills Process validation and computer software validation knowledge Ability to apply statistical techniques to analyze data and develop\/review\/approve test plans and reports Experience in medical devices manufacturing Interpersonal skills to support product disposition investigations (PFMEA, atypical events) Automated source code management Computer software programming (including embedded software programming) Development of control plans and PFMEA Additional Technical Areas (Hands\-On\/Knowledge Required) Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting Vision Systems Instrumentation: overview and application Control Systems Data Structure & Sources Data Analysis Tools: SQL, Python, R Data Management Databases: data extraction, transformation, loading, database creation\/maintenance, query overview (SQL\/Non\-SQL) Programming: Assembly (C), Object\-Oriented Programming (Python, Java), error handling, abstract data types GUI\/HMI Design: FactoryTalk, RSView Communication Networks Operating Systems FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022) Nice to Have Additional investigation and root cause analysis expertise *Willing to work 1st or 2nd shift and 100% on\-Site in Juncos.* "}}],"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":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Principal Software Quality Engineer","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017078001","FontSize":"15","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}