Test engineer jobs in Guaynabo, PR

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * CQV Specialist Smoke Testing / Airflow Visualization Overview The CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing. Key Responsibilities * Plan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments. * Set up and qualify smoke/fog generation equipment, lighting, and video recording systems. * Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps. * Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems. * Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence. * Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues. * Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance. * Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500. * Support regulatory inspection readiness and provide airflow-related technical responses. Required Qualifications * Bachelors in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field. * 5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning. * Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification. * Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS. * Ability to interpret airflow patterns and provide engineering recommendations. Preferred Skills * Experience with particle counters, differential pressure monitoring, BMS/EMS systems. * Experience qualifying sterile filling lines or aseptic equipment. * Knowledge of HVAC balancing, cleanroom design, and environmental controls.

Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Monitors and tracks all sources of quality detractors utilizing the service database and complaint database. Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations. Develops solutions to database problems of moderate scope and complexity. Writes and assists others in writing standard operating procedures. Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams. Provides advanced technical assistance in the use of information mapping technology. Provides support to product review and release functions. Generates moderately complex statistical summaries. Provides support to good manufacturing practice auditing. Requirements Minimum 2 years of experience with Investigations and complaints. Work experience with quality system in the pharma industry is acceptable. Bachelor's degree in Science completed. Willing to work 100% on\-site Gurabo. "}}],"is Mobile":false,"iframe":"true","job Type":"Contract","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Pharma\/Biotech\/Clinical Research"},{"field Label":"City","uitype":1,"value":"Gurabo"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00778"}],"header Name":"Analyst 2 \- Quality Assurance","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016530006","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26rdEozDrUdYhKge.sh YqcHw\-&embedsource=Google","location":"Gurabo","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leaders headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Automation Engineer is primarily responsible for the maintenance, development and/or configuration of control systems codes for reliable operation of manufacturing processes, and the existing automation systems, the front-line support for manufacturing process automation support for the Lilly PR05 Facilities on Carolina PR. Will work with cross function team to troubleshoot issues for reliable operation of automation systems. Will be supporting day to day automation activities, driving appropriate GMP change control/deviation, preparing/adhering project schedules, and programming process control systems, as applicable. Will be providing technical support for daily manufacturing operations and for the specification, installation, start-up and validation support of process equipment projects. As applicable, other duties include interfacing with Maintenance, Tech, Engineering, and Manufacturing personnel as required to coordinate plant shutdowns, prepare, and review Operational SOP's and Functional Requirement Specification (FRS), lead projects activities, and represent automation group in several process meetings. Ensure compliance with data integrity and be accountable of the system life cycle. Main Responsibilities: * Be a Subject Matter Expert for Rockwell Automation's PLCs and HMIs codes or DeltaV System code of the designated area * Provide frontline support and troubleshoot DeltaV, PLC and HMI codes and electrical equipment, as applicable * Professional experience to work independently with minimum supervision * Deliver professional Automation support representing the Automation Engineering on cross functional process teams, possibly for data analytics and reporting, as applicable * Leading equipment and process troubleshooting efforts, Root Cause Analysis, and deviation, as applicable * Implementing continuous improvement projects, possibly for data review/monitoring, audit trails, as applicable * Interacting regularly with Manufacturing, Maintenance, Process Engineers, Validation and Quality and other functions, as needed * Data monitoring and analysis for process improvements and issue resolution for applicable departments * Author, review, and approve change controls, deviation investigations, standard operating procedures (SOPs), drawings, schematics, work orders, etc. * Identify process automation and Data Integrity knowledge gaps that impact equipment and process capability, as applicable. * Manage control systems assets through the life cycle. * Understand how the instrument communicates with the control system. * Understand interfaces and data flow. * Understand (or participate in the development) of the Data Integrity Strategy. Provide engineering support and project management by: * Maintaining and enhancing the Process Control and other Systems, as applicable * Developing the project scope, including user requirement, design, functional specifications, and engineering drawings * Influencing functional groups regarding operability, technical feasibility, engineering design, maintenance, spare parts, installation/shut-down coordination, project schedule and validation/documentation requirements * Arranging for procurement of equipment and instrumentation required for the projects * Working with professional consultants and mechanical contractors to develop design and construction drawings/specifications and to implement and test the changes * Leading installation, start-up, commissioning and qualification activities Provide technical support to ensure continuous production: * Keep up to date with required training. Develop expertise by attending technical seminars and training sessions * Grow and develop each year as an individual. Develop deep skills and knowledge. Deliver results consistently * Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically. Basic Requirements: * Bachelor's degree in Engineering. * Minimum 2 years of experience. * Experience and knowledge of DeltaV, PLC and instrumentation (smart and conventional) is highly recommended. * Experience in pharma or GMP industry * Experience with Computer System Validations (CSV) * Experience in Project Management * Knowledge about Operational Excellence Lean Manufacturing * EIT Licensed (required) * Bilingual (Spanish/English) * Effective teamwork and collaboration skills * Excellent communication skills at all levels * Strong compliance mindset and sound judgment * Availability to support a 24/7 operation * Availability to travel within and outside of Puerto Rico and the U.S. Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $52,500 - $154,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

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.

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.

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, changes specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Provides or directs verification and validation of software system requirements, traceability, and testability. Qualifications: Bachelor's degree in Engineering: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Minimum of 7 years of experience on field (quality - excluding experience laboratory micro/chemistry) or engineering or programming Experience with Risk management documentation: pFMEAs Basic knowledge in PLC, general programming, Source Code Review (e.g. Automation/ Controls / Programming hands on experience) Computer Software validations/GAMP knowledge - hands on experience Basic knowledge in Root Cause Analysis CAPA/ Investigations/ Root Cause Analyses/Technical Writing Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Knowledge in Medical Devices regulations Knowledge in GAMP Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends. Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For 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?

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 Validation Engineer will support Validation/Qualification activities in a Medical Devices manufacturing environment. Minimum Requirements: Bachelor Degree in Engineering Field (Mechanical, Electrical, Industrial Engineers preferred). Experienced in Medical Devices and/or Pharmaceutical manufacturing environments. Knowledge in 21 CFR Part 820 regulation. Experienced (3-5 years) in the development and execution of validation documentation and protocols, including; Validation Assessments, Validation Plans, Requirements Specifications (URS, FRS), IQ, OQ, PQ and Reports. Good technical writing skills in English and Spanish. Experience developing and implementing Measurement System Analysis (MSA), including; Attribute Analysis, GR&R, DOEs. Experience in Minitab (software statistical tool). Project management skills required. Fully bilingual (English and Spanish). Job Types: Full-time, Contract Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Work Location: In person

Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and employees. Through Genesys Cloud, the AI-powered Experience Orchestration platform, organizations can accelerate growth by delivering empathetic, personalized experiences at scale to drive customer loyalty, workforce engagement, efficiency and operational improvements. We employ more than 6,000 people across the globe who embrace empathy and cultivate collaboration to succeed. And, while we offer great benefits and perks like larger tech companies, our employees have the independence to make a larger impact on the company and take ownership of their work. Join the team and create the future of customer experience together. Job Summary Join the global Innovations team at Genesys to build and scale cutting-edge generative AI applications. This team is at the forefront of innovation, delivering custom applications, integrations, and AI-driven solutions for Genesys Cloud environments. We're looking for an experienced full-stack developer with deep knowledge of AWS, Python, and generative AI technologies. Key Responsibilities * Design and develop generative AI applications using Python and AWS Bedrock. * Automate business practices through AI-driven solutions. * Collaborate with DevOps engineers to architect and manage AWS-based infrastructure for cloud contact center solutions. * Maintain and optimize AWS operational configurations, including resource management, permissions, usage scripting, and alerting. * Implement deployment automation and CI/CD pipeline practices. * Ensure cloud security and apply best practices to minimize vulnerabilities. * Develop applications using NodeJS and ReactJS, targeting Lambda functions and containerized deployments. * Respond to and resolve cloud infrastructure support tickets. Required Qualifications * Bachelor's or Master's degree in Computer Science, Computer Engineering, or related field. * Must be able to work in the United States (now AND in the future) without needing visa sponsorship. * 4+ years of full-stack software development experience using Python, NodeJS, and ReactJS. * 2+ years of experience developing and deploying SaaS solutions on AWS. * Hands-on experience with container technologies such as Docker or Kubernetes. * Proven understanding of generative AI, including large language models (LLMs), Agentic AI, and diffusion models. * Experience with models such as OpenAI ChatGPT, Anthropic Claude, Google Gemini, and Hugging Face. * Skilled in deploying solutions across both Windows and Linux environments. * Proficient in building responsive web UIs with ReactJS; familiarity with AngularJS or jQuery is a plus. * Familiarity with Genesys APIs and cloud services. * Strong analytical and troubleshooting skills in software operations. * Experience with database administration and performance optimization. * Comfortable in Agile environments with strong collaboration and independent work skills. * Experience with automated testing, CI/CD, and modern DevOps practices. Preferred Qualifications * Experience supporting enterprise-scale contact center environments. * Exposure to customer-facing software deployments in a services-led delivery model. * Interest in emerging AI models and rapid prototyping. Compensation: This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location. This role might also be eligible for a commission or performance-based bonus opportunities. $93,200.00 - $173,200.00 Benefits: * Medical, Dental, and Vision Insurance. * Telehealth coverage * Flexible work schedules and work from home opportunities * Development and career growth opportunities * Open Time Off in addition to 10 paid holidays * 401(k) matching program * Adoption Assistance * Fertility treatments Click here to view a summary overview of our Benefits. If a Genesys employee referred you, please use the link they sent you to apply. About Genesys: Genesys empowers more than 8,000 organizations worldwide to create the best customer and employee experiences. With agentic AI at its core, Genesys Cloud is the AI-Powered Experience Orchestration platform that connects people, systems, data and AI across the enterprise. As a result, organizations can drive customer loyalty, growth and retention while increasing operational efficiency and teamwork across human and AI workforces. To learn more, visit **************** Reasonable Accommodations: If you require a reasonable accommodation to complete any part of the application process, or are limited in your ability to access or use this online application and need an alternative method for applying, you or someone you know may contact us at reasonable.accommodations@genesys.com. You can expect a response within 24-48 hours. To help us provide the best support, click the email link above to open a pre-filled message and complete the requested information before sending. If you have any questions, please include them in your email. This email is intended to support job seekers requesting accommodations. Messages unrelated to accommodation-such as application follow-ups or resume submissions-may not receive a response. Genesys is an equal opportunity employer committed to fairness in the workplace. We evaluate qualified applicants without regard to race, color, age, religion, sex, sexual orientation, gender identity or expression, marital status, domestic partner status, national origin, genetics, disability, military and veteran status, and other protected characteristics. Please note that recruiters will never ask for sensitive personal or financial information during the application phase.

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, 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 (***************************************************************************************************************************

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.

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"}

For Engineering services in the Manufacturing area, supporting the introduction of a new product. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering & two (2) years of exposure in the Medical Device or Pharmaceutical Industry Bilingual (Spanish & English). Shift:1st, 2nd, and according to business needs. Experience in: Line Layout, Infrastructure Development, and Drawing Interpretation. Process Development and Documentation Process Validation Lifecycle (IQ, TMV, OQ, PQ, PFMEA, Process Characterization). SOP Development The Personality Part: If you seek humanity's well-being, are oriented to improve collective health while promoting a long life without pain, then this is a job for you. You can achieve this by applying your interpersonal skills and analytical capacity without losing sight of the effectiveness and quality of your results. If you think you got all this (and more!) then bring it on! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Design and plan layout for activities such as machining, metal forming, plastics processing, welding, and brazing, assembly, and materials handling. Adapt machine or equipment design to factory and production conditions. Design arrangement of machines within plant facilities to ensure most efficient and productive layout. Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Comply with company programs, procedures and applicable quality system regulations and standards. 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?

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 working and executing Design transfer activities. Must be available to work all shifts and overtime. 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.

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 ( 1st & 2nd Shift)","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"}

For CQV services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with eight (8) years of experience as a C&Q Engineer within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management skills. Shift: Administrative, and according to business needs. Experience in: CQV Validation Expert: Risk-based qualification methods (ASTM E 2500) for pharmaceutical manufacturing equipment and utilities Sterilization & Cleaning Specialist (SME): CIP and SIP processes GMP Document Controller: Validation Protocols (IQ/OQ/PQ), Risk Assessments, and leading Root Cause Analysis (RCA) for quality issues. Engineering Project Support: P&IDs and FAT/SAT. The Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Review and/or Approve Lifecycle Documents, including but not limited to User Requirements, Risk Assessments, Data Integrity Assessments, Commissioning and Qualification Plans, Validation Plans, Installation, Operational and Performance Verification (included but not limited to Clean Utilities such as APR, WFI, SCL, and PW) protocols and reports Support field execution of commissioning/integration testing required by the C&Q Plan. Evaluate and approve protocol discrepancies/deviations with direct support in the Root Cause Analysis. Review engineering change notices and evaluate/propose modifications to the qualification strategies Participate in engineering design phases and propose strategies to assure successful qualification and start-up. Anticipate potential pitfalls based on regulatory /compliance guidance Apply Risk-Based Validation approaches based on Amgen Standard Operating Procedures and industry guidance Create and/or revise SIP drawings (~65) for Upstream and Downstream impacted circuits. Participate in project weekly meetings, such as Detail Design Technical Meeting and Slowdown Window Workshops for Upstream, Downstream, and Clean Utilities. Participate in risk assessments to identify potential hazards and implement appropriate controls, including, but not limited to, reviewing and approving the risk assessment report. Process and Equipment understanding, which includes P&IDs walkdown with engineering and determination of impacted circuits (product/non-product contact). Provide SME support to engineering phases, including basis of design, detailed design, risk assessments, and align the commissioning execution strategy with the CQ Service Provider (e.g., FAT, SAT, Set to Work, Safety, Maintenance, Receipt Verification, Installation Verifications, Functional Testing, etc) Clean In Place (CIP) expertise, which includes, but is not limited to, cycle development, cleaning studies, worst case determination, protocol, and report preparation. Steam In Place (SIP) expertise, including but not limited to Thermal, Biological Indicator, and Microbial Challenge testing to assess the effectiveness of the sterilization process and protocol, and report preparation. Evaluates and documents the commissioning and qualification impact to proposed critical system changes through the Change Control Program, if necessary. 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?