Test engineer jobs in San Juan, PR - 167 jobs

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.

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.

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

General Summary: 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. Duties & Responsibilities: 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. ​ *Other duties may be assigned. * Requirements Minimum 2 to 4 years of experience in the regulated industry. Experience with Investigations and complaints. Experience with quality system in pharma industry is acceptable. Bachelor Degree completed. Bilingual. Willing to work 100% on\-site in Gurabo. 1st shift (Monday to Friday) "}}],"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":"Pharma\/Biotech\/Clinical Research"},{"field Label":"City","uitype":1,"value":"Gurabo"},{"field Label":"State\/Province","uitype":1,"value":"Gurabo"},{"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":"118922000017132001","FontSize":"15","location":"Gurabo","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

Country: United States of America Hybrid 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 The Global Engineering Center in Puerto Rico is looking for a Software Engineering II professional, with Verification & Validation experience, to join our team. We are looking for a strong, passionate problem-solver with an action-oriented, collaborative mindset who strives to exceed expectations. This person will be in a cross disciplinary team environment and will need to be able to thrive on tackling challenges, as the position requires the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate design or process changes. This position will sit at our Aguadilla, Puerto Rico location. You must be residing in Puerto Rico at the time of starting employment. Relocation is not offered. This role is categorized as hybrid, with 3 days onsite and 2 days remote following the schedule assigned by the Manager. What You Will Do: Measures and analyzes software designs for equipment/products to ensure current and future needs of the business are met. Builds and implements procedures that are used to support hardware and software product development and functions. Operates equipment and computer systems for testing and software design purposes to facilitate operations and ensure that established objectives are achieved. Designs, develops, documents, tests and debugs control and diagnostic systems that contain logical and mathematical solutions. Conducts multidisciplinary research and collaborates with equipment designers in the planning, design, development, and utilization of electronic data processing systems for product and commercial software. Determines end user needs by analyzing system capabilities to resolve problems on program intent, output requirements and input data acquisition. Develops test procedures and code for various UNIX operating systems (Linux & others) and Windows What You Will Learn: You will learn about our growing engineering team in Puerto Rico; What we do. Who we support. How we work. You will learn the technologies of today and tomorrow which we count on to maintain world leadership in the aerospace industry. You will learn why people enjoy and feel fulfilled by working in our industry. Qualifications You Must Have: Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 2 years of prior relevant experience or an Advanced Degree in a related field Experience with software development or, computer/electronic equipment Demonstrated professional experience communicating in English (verbal and written) Qualifications We Prefer: Experience in software development and verification based on DO-178 Experience with Software Lifecycle & Agile software development Experience with HLR/LLR and Requirements decomposition Experience conducting test planning & unit- tests Experience in code review or performance monitoring Knowledge of Python; ADA Experience using C/C++ Experience in National Instruments LABVIEW Experience with communication buses (ARINC-429, ARINC-664, CAN, TTP) Experience with Linux and/or Windows System Administration Experience in Hardware/Software integration and troubleshooting What We Offer: Some of our competitive benefits package includes: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds Participation in the Employee Scholar Program (ESP) Life insurance and disability coverage Employee Assistance Plan, including up to 8 free counseling sessions. And more! Learn More & Apply Now! Collins Aerospace, an RTX business, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Join our growing engineering team in Puerto Rico, where you will provide critical support to all Collins SBUs, working on exciting programs and projects ranging from the development of the next generation of advanced concept ejection seats to the latest technologies for the U.S. warfighter. WE ARE REDEFINING AEROSPACE. * Please consider the following role type definition as you apply for this role. Hybrid: Employees who are working in Hybrid roles will work regularly both onsite and offsite. Ratio of time working onsite will be determined in partnership with your leader. 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

Responsible for designing, executing, and document equipment and processes validations following procedures of and quality regulations of the client. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Develop and execute IQ, OQ, and PQ protocols for product, processes, facilities, software and equipment within the client's facility. Review existing validation reports and identifies gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Provide guidance and understanding on all equipment qualification methodologies as required by Pharmaceutical\/Medical Device industry within client's site. Participates on project teams to create and\/or approve (as applicable) the following: equipment & software risk management documentation, equipment design reviews, equipment verification and validation documentation. Support manufacturing\/quality\/engineering teams in the area of Process Validation to ensure that equipment related risks are identified and mitigated accordingly through testing. Assist in risk assessment activities (i.e. process map, value stream map, fish bone diagram, etc.) for equipment improvements or new equipment\/process development. Support activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with client's specifications. Requirements BS Degree in Engineering or Applied Sciences. One (1) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- Proven experience working with problem solving skills and familiarity with DMAIC problem solving tools. "}}],"is Mobile":false,"iframe":"true","job Type":"Contrato","apply Name":"Apply Now","zsoid":"664728484","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Industrial"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Validation Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054025","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjrPYKQrk3zx6cpCvFlkiYYk\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

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

Responsibilities: Assist in qualifying sales leads from an Engineering standpoint. Serve as a trusted technical advisor to customers and sales teams. Lead technically sales meetings with customers to understand their Cybersecurity challenges and requirements and align them to Fortinet solutions and services. Be the main technical resource on sales meetings to answer and collaborate with customers around Fortinet solutions features, specifications, and functionalities. Build cybersecurity solutions and Bill of Materials aligned to customers' needs and requirements. Conduct technical presentations of Fortinet products and solutions. Lead the technical sales activities like assisting partners with RFPs, RFIs, demonstrations, Proof of Concepts, ensuring Fortinet's solutions exceed customer expectations. Act as the primary technical contact for customers and partners, collaborating closely with Account Managers, demonstrating Fortinet's valued proposition. Be able to clearly understand, articulate and deliver Fortinet's value proposition, to customers and partners. Be a presenter in internal or external meetings, like events, Executive Briefing Centers (EBCs), Marketing activities, or any market positioning activity. Manage multiple opportunities effectively while maintaining exceptional customer experiences, with a great report within internal tools. Proactively manage internal and external communications including calls, emails and chats based on the predefined SLAs. Stay ahead of cybersecurity trends and Fortinet's product offerings. Required Skills and experience: 3+ years of experience in Security Operations Teams (Blue Team, Red Team, SOC Manager, Senior SOC Analyst). 3+ years in Network Security (LAN/WAN and WLAN Admin/Manager) with experience with NGFW/SDWAN technologies, Large Campus and Datacenter Networking solutions. 2+ Years of experience in pre-sales engineering roles is a plus. Deep understanding of enterprise network security architectures, industry cybersecurity frameworks, and regulations such as NIST, MITRE ATT&CK, COBIT, PCI-DSS, FERPA, HIPAA and Zero Trust. Strong understanding of Enterprise Cybersecurity and Network Architectures. Knowledge of the following concepts: Network Security, Security Operations, Cloud Technologies, Secure Access Service Edge, Network Access Control. Strong understanding in the following technologies and protocols: RADIUS, LDAP, PKI, IKE, Certificates, L2TP, VXLAN, IPSEC, 802.1Q, AES, SSH, TLS/SSL, SHA. Understanding of Private and Public Cloud environments like VMWare, Hyper-V, Kubernetes, GCP, AWS, Azure, OCI, Nutanix. Experience with modern encryption, authentication and IAM technologies Strong understanding in the following solutions: SIEM, SOAR, EPP, is a plus Strong communication and interpersonal skills, with ability to work effectively with technical and non-technical teams. Strong problem-solving and analytical skills. Professional proficient in English, being able to effectively participate in technical discussions, internal and external meetings, and written communication. Education and Certifications: Bachelor's Degree or equivalent experience. CISSP, CISM, CISA, CCSP, CEH, GSEC, OSCP, TOGAF or other professional level credentials/accreditations are a plus. Fortinet Certifications (FCP, FCSS, FCX) are a plus Cloud Certifications from a well-known vendor is a plus.

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Validation Engineer - Process Development. Requirements: * BS Engineering with at least 3 years of medical devices or pharma experience. * Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. * Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. * Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. * Design and develop in-process and receiving quality systems for new processes and components. * Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. * Define gages, tools and equipment for the test methods developed. * Generate manufacturing instructions for new processes being developed. * Work cross-functionally with other departments to accomplish PD tasks.

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

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

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 CompaniesAffiliated 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

**_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, will be responsible for overseeing the end-to-end data migration strategy for SAP implementation projects. The role requires deep technical expertise in SAP data architecture, data migration tools to ensure successful, high-quality, and efficient data conversion process. **_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 define the overall data migration architecture, including the approach, tools, and best practices for converting data from various legacy systems into the new SAP target system. + Lead the selection and configuration of SAP data migration tools such as SAP Data Services, SAP S/4HANA Migration Cockpit, and SAP Landscape Transformation (SLT). + Create detailed technical and functional specifications for data mapping, transformation rules, and data validation. + Establish and enforce data quality and governance standards for the entire data migration lifecycle. + Lead and manage the entire data conversion team, including developers, business analysts, and data stewards. + Oversee the execution of data migration cycles, including mock conversions, cutover planning, and post-go-live data reconciliation. + Collaborate with key stakeholders, including business leaders and project managers, to align the data conversion strategy with overall business objectives and project timelines. + Provide expert guidance and technical leadership to resolve complex data conversion challenges and performance issues. + Serve as the subject matter expert on SAP data structures (e.g., master data, transactional data), data integration methods, and data governance principles. + Ensure compliance with project standards, security policies, and regulatory requirements throughout the data conversion process. + Partner with other technical architects (e.g., infrastructure, security) to ensure the data conversion solution is scalable, secure, and aligns with the enterprise architecture. + Mentor and provide technical leadership to junior team members. **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + 8+ years of experience with SAP implementations and ABAP knowledge in respective business processes like Master data, OTC, PRI, SCE, RTR and PTP preferred. + 3-5 years of experience with SAP Data Services and Data conversions preferred. + Experience in ALE/IDOC, LSMW, RDM/BPDM + Demonstrates a knowledge of Master Data Management domain + Ability to define work processes and lead team members in successful implementation and ongoing execution preferred + Ability to develop individuals and teams preferred + Excellent oral and written communication skills preferred + Excellent organizational skills preferred **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 (***************************************************************************************************************************

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

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: Validation Engineer - Process Development Purpose Statement Engineer, Validations: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering. Key Responsibilities: Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. Design and develop in-process and receiving quality systems for new processes and components. Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. Define gages, tools and equipment for the test methods developed. Generate manufacturing instructions for new processes being developed. Work cross-functionally with other departments to accomplish PD tasks. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 - 5years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in medical devices operations. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge (according to related area). Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.

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"}

Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation. Define appropriate measures to ensure product quality. Develop overall operating criteria to ensure implementation of the software quality program in compliance with project, process, and contract requirements. Ensure project and process control documentation meet requirements, objectives, and\/or contracts. Review software systems design, change specifications, and plans against contractual and\/or process requirements. Assess specifications, materials, tools, techniques, and methodologies for compliance. Provide or direct verification and validation of software system requirements, traceability, and testability. Perform other duties as assigned. Requirements Minimum 3 years of field experience in Quality, Engineering, or Programming in the regulated industry. Experience with risk management documentation (pFMEAs). Basic knowledge in PLC, general programming, and source code review. Ability to support CAPA investigations and provide technical writing. Knowledge of designing and reviewing validation strategies (requirements flow down from design to manufacturing). Ability to perform and\/or review process\/equipment validation documentation: URS, FAT, IQ, OQ, PQ, TMV (not laboratory). Familiarity with Medical Device Regulations and GAMP guidelines. Technical Skills (Must Have) Investigation and root cause analysis skills. Technical writing knowledge. Strong organization and communication skills. Process validation and computer software validation knowledge. Ability to use statistical techniques to analyze data. Experience in medical device manufacturing. Interpersonal skills to investigate and collaborate in atypical event investigations. pFMEA development and review. Automated source code management. Computer software programming. Embedded software programming. Development of control plans and PFMEA. Nice to Have Additional experience with investigation and root cause analysis. Top 3 Priorities in Candidate's Experience Automation, controls, and programming hands\-on experience. CAPA, investigations, root cause analysis, and technical writing. Computer software validations and GAMP knowledge (hands\-on). *Willing to work 100% On\-site in Juncos, 1st and 2nd shift.* "}}],"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":"Software Quality Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017030019","FontSize":"15","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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