Engineer jobs in Caguas, PR

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Work with Manufacturing to develop user requirements for AML6 capital projects Develop project schedule of installation and qualification activities. Work directly with construction and C&Q contractors to deliver project deliverables. Administer the implementation and closeout of projects Communicating and reporting to site leadership on project matters. Monitoring and evaluating engineer/contractors physical progress. Addressing progress and delay claims from contractors. Reviewing and approving engineer change orders and invoices. Preparing monthly project status reports for senior management both on site. Developing and monitoring project schedules. Technical Abilities Required: The Project Engineer must have strong technical experience working on small projects supporting industrial process equipment and biotechnology manufacturing facilities including C&Q & start up activities for Manufacturing facilities. Qualifications Requirements/Knowledge/Education/Skills: Bachelor degree in Engineering & 2 years of Engineering experience. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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.

Designs and plans layout for such activities as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs 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. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to Engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure compliance with company programs procedures and applicable quality system regulations and standards.

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

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?

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.

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

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

At INVID, we're seeking a highly skilled and motivated AWS Application Engineer to drive the automation, scalability, and reliability of our cloud infrastructure. What sets INVID apart is our collaborative and flexible work environment. We encourage our team to raise the bar in everything they do while maintaining a healthy work-life balance. With our hybrid work model, team members thrive both in the office and remotely. We foster a culture of mutual respect, autonomy, and accountability, where your voice matters and your growth is supported. From structured career paths and paid professional development to access to industry events, we're committed to your success. Responsabilities: Analyze application architecture and dependencies to determine migration readiness. Work with architects to design migration strategies (Rehost, Replatform, Refactor) for various workloads. · Assist in the migration of applications to AWS using tools like AWS Application Migration Service (MGN), AWS Database Migration Service (DMS), and AWS Elastic Beanstalk. Ensure proper deployment, configuration, and performance of applications in AWS environments. Troubleshoot application issues and ensure smooth functioning in the new AWS environment. Optimize applications for performance, scalability, and cost efficiency. Configure applications to utilize AWS services like RDS, S3, Lambda, DynamoDB, and CloudFront. Set up monitoring and logging for applications using AWS CloudWatch, X-Ray, and third-party tools. Collaborate with DevOps engineers to automate application deployments using AWS CodePipeline, CodeDeploy, or Jenkins. Develop scripts for repeatable application setup and provisioning using Infrastructure as Code (IaC) tools like AWS CloudFormation or Terraform. Work closely with architects, QA engineers, and stakeholders to ensure migration objectives are met. Actively participate in Scrum ceremonies, including sprint planning, daily stand-ups, and retrospectives. Document application changes, migration steps, and configurations. Share knowledge with team members to ensure consistent understanding of application and migration processes. Requirements: Minimum of 3+ year experience in a security engineering role, with experience in network security, application security, and security frameworks. Bachelor's degree in related area and / or equivalent experience / training. Strong understanding of AWS services like EC2, S3, RDS, Lambda, and VPC configurations. Familiarity with AWS migration tools, such as AWS MGN, DMS, and Migration Hub. Experience in deploying, configuring, and managing applications in cloud environments. Knowledge of microservices architecture and containerization tools like Docker and ECS. Proficiency in scripting languages such as Python, Shell, or PowerShell for automation. Experience with Infrastructure as Code tools like Terraform, AWS CloudFormation, or CDK. Hands-on experience with monitoring tools like AWS CloudWatch, X-Ray, or third-party solutions like Datadog. Strong problem-solving skills for application performance and dependency issues. Experience working in Scrum or Agile teams, adhering to iterative delivery and collaborative practices. Strong analytical and troubleshooting abilities. Excellent communication and teamwork skills. Ability to manage multiple priorities in a fast-paced environment. Excellent computer proficiency including JIRA Nice to have skills: Understanding of advanced services like AWS Step Functions, EventBridge, and Aurora. Experience with AWS serverless technologies like API Gateway, Lambda, and DynamoDB. Familiarity with CI/CD tools like GitHub Actions, Jenkins, or AWS CodePipeline. Knowledge of container orchestration tools such as Kubernetes (EKS). Experience in tuning application performance and cost optimization in AWS. Familiarity with caching solutions like ElastiCache or Content Delivery Networks (CDNs). Experience with migration validation, including data integrity, application functionality, and system dependencies. Ability to mentor junior engineers and contribute to team knowledge sharing. Proactive approach to identifying and resolving migration challenges. AWS Certified Developer - Associate or AWS Certified Solutions Architect - Associate Bilingual: English and Spanish US Citizen | US Resident Location: San Juan, PR EEO

**Role:** As a Principal Staff Artificial Intelligence Engineer within the Simulation and Testing organization, you will play a critical role in leading the strategy and execution of simulation-based validation efforts for autonomous vehicle development. Your expertise will guide a team of engineers in defining best practices and driving innovation in testing and verifying the safety and performance of autonomous systems in complex simulated environments. You will be responsible for shaping the future of our simulation capabilities and ensuring robust validation methods are implemented effectively. **About the Organization:** The Simulation and Testing team is dedicated to advancing the development of autonomous vehicles through cutting-edge simulation technologies. We focus on creating realistic and challenging test scenarios that enable comprehensive evaluation of autonomous systems. Our collaborative environment fosters innovation and excellence, allowing us to push the boundaries of what is possible in autonomous vehicle testing. **What You'll Do:** + Lead the design, development, and implementation of simulation-based validation strategies for autonomous systems, ensuring safety and performance metrics are met. + Guide and mentor a team of engineers, fostering a culture of innovation and excellence in simulation methodologies. + Define and implement robust validation methods and sophisticated evaluation strategies within simulation frameworks, including the creation of challenging test scenarios and analysis of results at scale. + Collaborate cross-functionally with teams involved in autonomous system development to ensure seamless integration of simulation testing into the overall development process. + Influence technical roadmaps and strategic priorities, aligning simulation efforts with company objectives and product milestones. **Your Skills & Abilities (Required Qualifications):** + Master's in Robotics, Computer Science, Engineering, or a related technical field. + 10 years of extensive experience in simulation and testing, preferably within the autonomous vehicle domain. + Proven track record in developing or testing large-scale Machine Learning (ML) systems, with a strong understanding of simulation platforms and methodologies. + Direct experience leveraging LLMs/VLMs/etc. for production workflows. + Experience with the entire machine learning lifecycle from data generation and curation through model training through model deployment. + Hands-on expertise in implementing robust validation methods and evaluation strategies, including defining relevant metrics and correlating simulation performance with real-world behavior. + Strong software engineering skills, particularly in programming languages relevant to simulation and testing. + Excellent communication, collaboration, and mentoring abilities, with a passion for driving innovation in autonomous technology. **What Can Give You a Competitive Edge (Preferred Qualifications):** + Ph.D. in Robotics, Computer Science, Engineering, or a related technical field. + 15 years of extensive experience in simulation and testing, preferably within the autonomous vehicle domain. **Compensation** **:** The compensation information is a good faith estimate only. It is based on what a successful applicant might be paid in accordance with applicable state laws. The compensation may not be representative for positions located outside of the California Bay Area. + The salary range for this role is $193,000 - $296,600. The actual base salary a successful candidate will be offered within this range will vary based on factors relevant to the position. + Bonus Potential: An incentive pay program offers payouts based on company performance, job level, and individual performance. **Benefits:** GM offers a variety of health and wellbeing benefit programs. Benefit options include medical, dental, vision, Health Savings Account, Flexible Spending Accounts, retirement savings plan, sickness and accident benefits, life insurance, paid vacation & holidays, tuition assistance programs, employee assistance program, GM vehicle discounts and more. **Company Vehicle:** Upon successful completion of a motor vehicle report review, you will be eligible to participate in a company vehicle evaluation program, through which you will be assigned a General Motors vehicle to drive and evaluate. Note: program participants are required to purchase/lease a qualifying GM vehicle every four years unless one of a limited number of exceptions applies." **Remote:** This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View], you are expected to report to that location three times a week, at minimum. **This job may be eligible for relocation benefits.** \#LI-DO1 **About GM** Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all. **Why Join Us** We believe we all must make a choice every day - individually and collectively - to drive meaningful change through our words, our deeds and our culture. 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Develop Validations Documents (Master Validation Plans/Reports, Test Method Validations, IQ, OQ and/or PQ, CSV related documents), Execute Validations in assigned Manufacturing Areas, and generate Reports. Document and execute IQ for label printing, Implement Manufacturing processes changes through CCB. Able to implement EU MDR requirements (such as PIC card implementation, Manufacturing/PFMEA, FAI, manuals and new pins implementation / FW Configuration changes and other required activity per EU MDR requirements). Develop and/or revise PPM or DOTM as required. Support during submission documents review as applicable. Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: 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 (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. 1. Some experience in process validation , test method validation, CSV, handling of manufacturing process changes implementation (at packaging and/or manufacturing process flow). 2. Responsible, able to learn fast and adapts to continues changes in project schedule priorities as required. Able to coordinate and manage activities with multiple functions, able to apply problem solving techniques (critical thinking skills) to move roadblock without impact project schedule activities 3. Teamwork oriented, good communication skills, results oriented Education Required: Bachelor degree in engineering Years' Experience Required: Minimum of two years preferred with some experience, intermediate position. Willing to evaluate good potential candidates at entry level

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?

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.

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Assist in the design, development, testing, and implementation of engineering solutions. Perform basic calculations, modeling, simulations, or drafting as required. Prepare technical documentation, drawings, and reports. Collaborate with senior engineers to troubleshoot issues and propose improvements. Participate in project meetings, site visits, or inspections as needed. Ensure compliance with company standards, safety protocols, and regulatory requirements. Support continuous improvement initiatives and contribute to workflow optimization. Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Civil, Software, or related field). Strong analytical and problem-solving skills. Basic experience with engineering tools, software, or design platforms used in the field. Excellent communication and teamwork abilities. Attention to detail and willingness to learn new technologies and methods Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Job Description Senior Validation Specialist - Utilities and Facilities Position Summary The Senior Validation Specialist for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. The Validation Specialist ensures compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness. Key Responsibilities: 1. Commissioning Activities Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed air) and facilities (e.g., cleanrooms, environmental monitoring systems). Conduct FAT, SAT, and pre-qualification tests to verify system functionality. Troubleshoot and resolve technical issues during the commissioning phase. 2. Qualification & Validation Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities. Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification. Ensure systems meet performance requirements and GMP standards. Perform thermal mapping, pressure testing, and other critical tests as needed. 3. Documentation Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs. Document deviations, CAPAs, and change controls associated with facilities and utilities systems. Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP). 4. Compliance and Risk Management Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO). Perform risk assessments and develop mitigation strategies for utility and facility systems. Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards. 5. Lifecycle Management Oversee requalification and periodic review of utilities and facilities systems. Manage system upgrades, decommissioning, and retrofits while ensuring GMP compliance. Collaborate with engineering and maintenance teams to ensure ongoing system reliability. 6. Cross-Functional Collaboration Partner with engineering, facilities, quality, and validation teams to ensure successful project execution. Coordinate with vendors and contractors during equipment installation and qualification. Provide support during internal and external audits and inspections. 7. Training Train facility and maintenance personnel on the operation and maintenance of qualified utilities and facilities. Skills Strong technical writing skills for protocol and report development. Proficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters). Excellent organizational and project management skills. Effective communication and troubleshooting abilities. Knowledge In-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities. Familiarity with validation guidelines (e.g., ICH Q9, ASTM E2500). Understanding of cleanroom classification and monitoring (ISO 14644-1, EU GMP Annex 1). Working Conditions Manufacturing plant and utility environments, including cleanrooms. Occasional travel for vendor FATs or external inspections. Flexibility to work extended hours or weekends during critical project phases. Qualifications Education Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field. Experience Minimum 8 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment. Hands-on experience with systems such as HVAC, purified water, clean steam, compressed air, and cleanrooms. Familiarity with environmental monitoring and building management systems (BMS) Certification in validation or engineering disciplines (e.g., ISPE, ASHRAE). Experience with utilities automation systems (e.g., SCADA, PLCs). Knowledge of energy efficiency principles and sustainability practices for facility systems. Additional Information All your information will be kept confidential according to EEO guidelines.

At INVID, we're looking for a highly skilled and motivated Azure Application Engineer to lead the automation, scalability, and reliability of our cloud infrastructure within the Microsoft Azure ecosystem. This role is essential in bridging development and operations, ensuring seamless CI/CD pipelines, secure deployments, and a resilient cloud architecture. The ideal candidate is passionate about Infrastructure as Code, cloud-native technologies, and driving continuous improvement. You'll collaborate closely with our development, QA, and security teams to implement best practices in DevOps and cloud security, while optimizing performance, cost-efficiency, and system resilience. Requirements: Analyze application architecture and dependencies to determine cloud readiness and define migration strategies (Rehost, Refactor, Replatform). Collaborate with architects to ensure application design aligns with Azure cloud best practices. Assist in migrating applications to Azure using tools like Azure Migrate, Database Migration Service (DMS), and Azure App Service Migration Assistant. Configure and deploy applications on Azure infrastructure, ensuring minimal downtime. Validate application functionality, data consistency, and system performance after migration. Troubleshoot and resolve application issues to ensure seamless operation in the Azure environment. Configure applications to leverage Azure services such as Azure App Service, Azure SQL, Azure Functions, and Cosmos DB. Implement monitoring and logging solutions using Azure Monitor, Log Analytics, and Application Insights. Collaborate with DevOps teams to integrate applications into CI/CD pipelines using Azure DevOps or GitHub Actions. Develop scripts and automation workflows for repeatable application setup and configuration. Work closely with migration architects, cloud engineers, and QA teams to ensure successful migrations. Actively participate in Scrum ceremonies, including sprint planning, daily stand-ups, and retrospectives. Maintain comprehensive documentation for application configurations, migration processes, and test results. Share insights and knowledge with team members to enhance overall migration efficiency. Requirements: Minimum of 3+ year experience in a security engineering role, with experience in network security, application security, and security frameworks. Bachelor's degree in related area and / or equivalent experience / training. Proficient in Azure services such as Virtual Machines, Azure App Service, Azure SQL Database, Storage Accounts, and Networking (VNets, NSGs). Experience with Azure migration tools like Azure Migrate, DMS, and App Service Migration Assistant. Strong experience in deploying, configuring, and maintaining applications in Azure environments. Familiarity with modern application architectures, including microservices and serverless computing. Proficiency in scripting languages such as PowerShell, Python, or Bash. Experience with Infrastructure as Code (IaC) tools like ARM templates, Bicep, or Terraform. Hands-on experience with Azure Monitor, Application Insights, and Log Analytics for application monitoring. Strong problem-solving skills for diagnosing application and system issues. Experience working in agile environments, participating in Scrum practices, and contributing to iterative delivery. Excellent analytical and troubleshooting skills. Strong communication and collaboration abilities. Detail-oriented with a focus on delivering high-quality outcomes. Strong analytical and troubleshooting abilities. Excellent communication and teamwork skills. Ability to manage multiple priorities in a fast-paced environment. Excellent computer proficiency including JIRA Nice to have skills: · Experience with advanced Azure services like AKS (Azure Kubernetes Service), Azure Logic Apps, and Azure Synapse Analytics. · Understanding of Azure Identity and Access Management (IAM) and security best practices. · Familiarity with Azure Cache for Redis and Content Delivery Networks (CDNs) for performance optimization. · Knowledge of scaling and tuning applications on Azure for cost-efficiency and performance. · Experience with CI/CD pipelines in Azure DevOps or GitHub Actions. · Knowledge of containerization and orchestration tools such as Docker and Kubernetes. · Proficiency in validating application functionality, data consistency, and workload dependencies during migrations. · Microsoft Certified: Azure Developer Associate or Azure Solutions Architect Expert. · Ability to mentor and guide junior engineers. · Proactive and adaptable in dynamic project environments Other Requirements: Must be bilingual (English and Spanish) Must be a US Citizen | US Resident Location: HYBRID in San Juan, Puerto Rico EEO

Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. 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. DIFFERENTIATING FACTORS Established and productive individual contributor. Works independently with general supervision on larger, complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal and external contacts. External interactions are mostly problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires an Engineering Degree (Mechanical Engineering preferred) and a minimum of 2 years of relevant experience. As part of the ME responsibilities, the person should be able to evaluate product, components and process (automated assembly lines, with automated inspections). The ME should be able to generate and evaluate Design of Experiments and other statistical tools required during the validation of the equipment or as part of Non-conformance evaluations. GMP and validations knowledge. The person should have initiative, team player, action oriented and great communication skills. 1. Troubleshooting process and equipment (electrical and mechanical) / Problem solving 2. Read and interpretate schematics 3. Automation inspection knowledge Education Required: Engineering, Mechanical Engineering Preferred

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?

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