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
$56k-74k yearly est. 12d ago
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QA engineer
Arival Pte Ltd.
Test engineer job in San Juan, PR
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.
$53k-60k yearly est. 4d ago
SAP Software Engineer - Data Conversions, Data Quality, and Reporting
Cardinal Health 4.4
Test engineer job in San Juan, PR
**_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 (***************************************************************************************************************************
$94.9k-135.6k yearly 60d+ ago
Software Engineer II - Development/Verification and Validation Testing (Hybrid - Aguadilla, PR)
RTX
Test engineer job in San Antonio, PR
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
$50k-59k yearly est. Auto-Apply 5d ago
Validation Engineer - Process Development
Pharma-Bio Serv, Inc. 4.3
Test engineer job in Dorado, PR
Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, one of our clients in the 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.
$55k-75k yearly est. 60d+ ago
Process Validation Engineer
Flexible & Integrated Technical Services
Test engineer job in Dorado, PR
For Process Validation services in the manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's in Engineering with five (5) years of experience in Process Validation activities within the Pharmaceutical Industry.
Excellent written and verbal skills in both English and Spanish.
Shift: Administrative and according to business needs.
Experience in:
Process and equipment validations.
Molding and Laser equipment.
Equipment troubleshooting and assessing process variation sources.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Generate technical justification to support and/or document process changes.
Design and develop experimental, engineering, or process validation protocols and reports supporting the implementation of operational, process, or raw material changes.
Support the execution of experimental, engineering, or process validation runs by providing technical assistance at the shop floor.
Maintain up-to-date process documentation (manufacturing directions, batch records, standard operating procedures) and assure they are in compliance.
Gather and analyze process data used to monitor process performance and generate product reports.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
$49k-68k yearly est. Auto-Apply 15d ago
Process Validation Engineer
Eqval
Test engineer job in Dorado, PR
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.
$49k-68k yearly est. Auto-Apply 12d ago
Validation Engineer
Professional Skills Developers
Test engineer job in San Juan, PR
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.
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$49k-68k yearly est. 60d+ ago
Systems Engineer
Fortinet 4.8
Test engineer job in San Juan, PR
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.
$63k-77k yearly est. Auto-Apply 60d+ ago
Jt095 - Prin Software Quality Engineer
Quality Consulting Group
Test engineer job in Juncos, PR
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
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.
$44k-54k yearly est. Auto-Apply 39d ago
Prin Software Quality Engr
Cencora, Inc.
Test engineer job in Juncos, PR
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
$44k-54k yearly est. Auto-Apply 42d ago
Prin Software Quality Engr
Cencora
Test engineer job in Juncos, PR
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
$44k-54k yearly est. Auto-Apply 41d ago
Software Quality Engineer II
Mg Staffing Group
Test engineer job in Juncos, PR
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.*
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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]
$49k-67k yearly est. 60d+ ago
SAP Software Engineer
Cardinal Health 4.4
Test engineer job in San Juan, PR
**_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 (***************************************************************************************************************************
$94.9k-135.6k yearly 60d+ ago
Principal Software Quality Engineer
Mg Staffing Group
Test engineer job in Juncos, PR
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.*
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$44k-54k yearly est. 60d+ ago
Project/Validation Engineer
Flexible & Integrated Technical Services
Test engineer job in Arecibo, PR
For Validation services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree and or an equivalent of three (3) years of experience in Industrial and Construction projects within the regulated industry.
Bilingual (Spanish and English).
Good organizational and problem-solving skills.
Shift: First (Monday-Friday) & according to business needs.
Experience in:
Process Validation and Development.
FDA, GMP, and ISO guidelines.
Statistical techniques (DOE, SPC).
Computer software knowledge (Microsoft Word, Excel, Power Point).
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Develops, manages, and executes cost improvement, product/process, and technology transfer projects.
Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
Conduct process equipment installation/operational/performance qualification studies to test their functionality .
Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Other duties as assigned.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
$49k-68k yearly est. Auto-Apply 47d ago
Jt468 - Validation Engineer II
Quality Consulting Group
Test engineer job in Juncos, PR
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory).
Experience in production line.
Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing).
Experience with Risk Management documentation: pFMEAs.
Basic knowledge in statistics (preferably using Minitab).
Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence).
Qualifications:
Bachelor's degree in Engineering (Mechanical, Electrical or Chemical preferred)
Minimum of 2 years of Engineering experience.
Knowledge in Medical Devices regulations.
Experience in GMP documentation.
Experience investigating manufacturing operations events in support to product disposition.
Experience assessing and tracing manufacturing defects/rejects trends.
Experience working and executing Design transfer activities.
Must be available to work all shifts, weekends and overtime.
Availability to work extended shifts (8- 12 hours per shift).
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
$49k-67k yearly est. Auto-Apply 33d ago
MV01-111925 Jr. Validation Engineer
Validation & Engineering Group
Test engineer job in Carolina, PR
Job Description
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Jr. Validation Engineer
Qualifications:
Bachelor's Degree in Engineering.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
The average test engineer in Bayamn, PR earns between $42,000 and $62,000 annually. This compares to the national average test engineer range of $60,000 to $104,000.