Project engineer jobs in Arecibo, PR

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

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.

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.

Engineer for equipment and process validation including IQ, OQ, TMV\/MSA, PQ protocol generation and execution.Will be hands\-on with automation, tooling, and maintenance technicians to coordinate and follow\-up on equipment troubleshooting , repairs or service required to assure that equipment validation is successful and for resolution of any deviation. Leads or leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies. Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Manages the development and implementation process of a company's products and services involving departmental or cross\-functional teams focused on the delivery of new or existing products and processes. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions to meet productivity, quality, and client\-satisfaction goals and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project's key stakeholders. Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems other duties may be assigned. Requirements Minimum 2 years in validation in the regulated industry. Project & Time Management Skills. Experience in equipment validations protocol generation, execution and report. Good time management skills to comply with timeline. Bachelor Degree in Engineering completed. Bilingual. Willing to work full On\-Site. "}}],"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":"Work Experience","uitype":2,"value":"2\-3years"},{"field Label":"City","uitype":1,"value":"Ponce"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00920"}],"header Name":"Validation Engineer \- Puerto Rico South Area","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015542107","FontSize":"15","location":"Ponce","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: The Project Engineer is directly responsible for the planning, execution, and implementation of engineering projects. Supports the manufacturing Process Engineers in the troubleshooting and optimization of manufacturing equipment. Position may be called to coordinate the transfer of equipment and processes as necessary. Perform all validation process. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) 1. Responsible for planning, scheduling, conducting, and coordinating the technical and management aspects of projects. 2. Accountable for the successful completion of engineering projects within the established deadlines. 3. Support the manufacturing floor by leading machine improvement and uptime activities. 4. Installs manufacturing equipment and provides training and technical support to Process Engineers and manufacturing personnel as required. 5. Responsible for the development and execution of Validation Protocols, Engineering Studies and Design of Experiment (DOE). 6. Develops preventive maintenance strategies and schedules. 7. Monitor performance metrics as yield, waste, machine efficiency; and provide recommendations for improvement. 8. Serve as focal point of contact between Engineering, Maintenance and Manufacturing during the implementation of the Manufacturing Process or Machinery Improvements. 9. Meet Federal, State and Local Regulations and Corporate Policies. Minimum requirements * Education: BS in Engineering required (BSME or BSEE Mechanical or electrical Preferred). * Experience: Minimum 3 years related experience in manufacturing of medical devices or pharmaceutical environment with exposure to ISO 9000 and QSR. (quality systems regulation) * Bilingual (Spanish & English). * Should be willing to temporarily relocate to Juncos for training. (3 months) Preferred Knowledge and Skills: * Knowledge in Statistical Techniques and DOE. * CIAPR license required. (or EIT). * Excellent presentation and project management skills; Quality and detail oriented. * Leader, team player, make things happen. * Project Management, Manufacturing, Validations. * Lean and/or Six Sigma methodology with a valid certification from an industry known trainer. Physical Demands: 1. Light work, which requires at times the carrying of up to twenty-five (25) pounds of audiovisual equipment. 2. Communication, coordination, hand-eye coordination skills. 3. Visual discrimination, up-close, far, 3-dimensional, peripheral, color scheme. 4. Occasional medium physical effort required in the execution of testing to support project phases. Work Environment: (if applicable) 1. Normal office working conditions. 2. Usually in a safe air-conditioned manufacturing environment. 3. Possible exposure to noise at manufacturing areas and dust during supervision of construction projects. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location USA PR - Anasco Additional Locations Work Shift NA (United States of America)

As a **Mechanical Design Engineer 2** , in the CDA organization, here at Honeywell, you will be a key contributor to the design and development of cutting-edge mechanical solutions. Your strong knowledge of mechanical design ethics and methodologies will ensure that the products developed under your guidance meet the highest standards of quality and reliability. Your proficiency in CAD software and other design tools will enable you to effectively oversee the design process and ensure the delivery of innovative and high-performance mechanical solutions. Component Design & Analysis (CDA) is a Center of Excellence responsible and accountable for the engineering design, analysis, development, certification and support of structural and mechanical systems components for all Aerospace power system products. CDA is responsible for ensuring the mechanical integrity of the structural parts used on gas turbine engines. These responsibilities include the design, development, testing, and field support of static structure components which must meet requirements for life, cost, weight, maintainability, and durability. You will report directly to our Engineering Manager, and you'll work out of our Aguadilla, Puerto Rico location. Applicant must have primary background and experience in the field of heat transfer. A working knowledge is required of convection attributes involved in laminar and turbulent flow, boundary layer theory, and general flow and energy balance calculations. Applicant should be knowledgeable in all radiation parameters and design considerations. Experience in finite element modeling should include conjugate heat transfer analysis as well as some basic stress and vibration analysis. The scope of work includes the creation and development of sound design solutions for newly proposed and existing products. Analytical results will be presented in design reviews and with appropriate documentation to meet program deliverables and requirements. **KEY RESPONSIBILITIES** + Perform 2D full-engine thermal-deflection analysis using ANSYS for the purposes of determining: + Component temperature gradients + Component radial tip clearances and axial clearances + Creation and development of sound design solutions for newly proposed and existing products + Work effectively with design teams, global teams and chief engineers. + Working productivity initiatives to advance the current state of the art and establish standardized processes for criteria, guidelines and practices. **_Travel, up to 10%, may be expected_** **YOU MUST HAVE** + Bachelor's degree from an accredited institution in a technical discipline such as the sciences, technology, engineering or mathematics + 2+ years of experience in a mechanical engineering field + 2+ years of heat transfer analysis experience using ANSYS FEA software + Ability to speak, write and read English **WE VALUE** + Bachelor's degree in mechanical engineering or a related field + Ability to guide and mentor junior engineers + Knowledge of the gas turbine engine industry + 3D modeling (CAD) and FEA (ANSYS, etc.) of gas turbine engine static structures and systems + Proven understanding and application of solid mechanics, dynamics, fatigue, and finite element analysis + Excellent communication skills (written and oral) are required to interact with engineering teams, other disciplines, and the customer + Knowledge of Six Sigma tools and application **BENEFITS OF WORKING FOR HONEYWELL** In addition to a performance-driven salary, cutting-edge work, and developing solutions side-by-side with dedicated experts in their fields, Honeywell employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance; Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance; Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and Paid Holidays. For more information visit: click here (******************************** **ABOUT HONEYWELL** Honeywell International Inc. (Nasdaq: HON) invents and commercializes technologies that address some of the world's most critical demands around energy, safety, security, air travel, productivity, and global urbanization. We are a leading software-industrial company dedicated to introducing state-of-the-art technology solutions to improve efficiency, productivity, sustainability, and safety in high-growth businesses in broad-based, attractive industrial end markets. Our products and solutions enable a safer, more comfortable, and more productive world, enhancing the quality of life of people around the globe. Learn more about Honeywell: click here (******************************** **THE BUSINESS UNIT** Honeywell Aerospace Technologies (AT) products and services are found on virtually every commercial, defense, and space aircraft in the world. We build aircraft engines, cockpit and cabin electronics, wireless engagement systems, mechanical components, and more, and engage many of them via our high-speed Wi-Fi offerings. Our solutions create healthier air travel, more fuel-efficient and better-maintained aircraft, more direct and on-time flight arrivals, safer skies and airports, and more comfortable flights, along with several innovations and services that reflect exciting and emerging new transportation methods such as self-reliant and supersonic flight. Revenues in 2023 for Honeywell Aerospace Technology were $14B and there are approximately 21,000 employees globally. To learn more, please visit click here (********************************* . The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates. Posted on 10/07/2025 **U.S. PERSON REQUIREMENTS** _Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. citizen, U.S. permanent resident, or have asylum or refugee status in the U.S._ Honeywell helps organizations solve the world's most complex challenges in automation, the future of aviation and energy transition. As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable. Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

For Validation services in the Engineering & Manufacturing areas. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry. Bilingual, Spanish and English (good communication) Shift: Administrative & according to business needs Experience in: SOP Development Validation Documentation GMP & GDP 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Write, execute and maintain on a timely basis Validation protocols. Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements. Ensure that all new and existing protocols are effectively integrated into manufacturing processes. Ensure documentation is thorough, accurate and entered on a timely basis into the quality system. Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing. Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements. Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents. Support the day to day process operations. 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?

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. 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: Bachelor's degree in engineering, life science discipline, or equivalent experience in the pharma/biotech industries. Highly capable of developing, executing, and reviewing validation life cycle protocols. Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments. Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations. Experience with validation and working knowledge of production is a plus. Familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP). Experience with Microsoft Office Suite. Experience Programing LabView require 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!

We are seeking a highly motivated and detail-oriented Project/Qualification Specialist to join our team. The successful candidate will be responsible for planning, executing, and documenting validation activities for equipment, processes, cleaning, software, and systems in accordance with internal procedures and industry regulations. This role plays a key part in ensuring that products are manufactured consistently and in compliance with FDA, ISO, and other regulatory standards. Requirements/Qualifications: Experience: • 2-5 years of experience in validation within the pharmaceutical, medical device, biotechnology, or manufacturing industry. • Hands-on experience with process, equipment, cleaning, and software validation. • Experience in troubleshooting and root cause analysis. Technical Skills: • Knowledge of validation methodologies (IQ, OQ, PQ) and protocols. • Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements. • Experience with risk assessment tools (FMEA, HACCP, risk matrix). • Proficiency in calibration and verification of instruments and equipment. • Ability to develop, execute, and document validation protocols and reports. • Proficient in using data analysis tools (Excel, Minitab, or equivalent). Soft Skills: • Strong analytical and problem-solving skills. • Excellent technical writing and documentation skills. • Ability to work independently and in a team-oriented environment. • Strong organizational and time management abilities. • Effective communication skills in English (written and verbal). Other Requirements: • Willingness to work in cleanroom or controlled environments. • Availability to work flexible hours, including weekends, if required. • Knowledge of safety procedures and compliance with EHS regulations Education & Certifications: • Bachelor's degree in engineering (Mechanical, Electrical, Chemical, Biomedical, or related field). • Advanced degree or professional certifications (e.g., Six Sigma, ASQ, CQE) is a plus.

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.

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

As a Mechanical Design Engineer I at Honeywell, you will impact the development of cutting-edge mechanical systems and components, collaborating with cross-functional teams to define requirements and specifications that enhance overall product performance. You will report directly to our Sr Engineering Manager, and you will work out of our Aguadilla, Puerto Rico location. At Honeywell, our people leaders play a critical role in developing and supporting our employees to help them perform at their best and drive change across the company. Help to build a strong, diverse team by recruiting talent, identifying, and developing successors, driving retention and engagement, and fostering an inclusive culture. **Key Responsibilities:** + Design and develop mechanical systems, components, and assemblies from concept to production. + Collaborate with cross-functional teams to define mechanical requirements and specifications. + Perform mechanical analysis and simulations to ensure product performance and reliability. **_Travel, up to 50% may be required._** **YOU MUST HAVE:** + Bachelor's degree from an accredited institution in a technical discipline such as the sciences, technology, engineering or mathematics + 1 plus years of experience in mechanical design and development. + Strong knowledge of mechanical design principles and methodologies. + 1 plus years of experience with CAD software and other design tools. + Experience with mechanical analysis and simulation tools. + Be able to read, write and speak English. **WE VALUE:** + Possess strong written and verbal communication skills, as the position demands the ability to represent the site in technical discussions with customers and/or regulatory agencies + Advanced Engineering degrees like ME (Mechanical Engineering). + Experience in aerospace or related industries. + Understanding of industry standards and best practices. + Knowledge of materials and manufacturing processes **BENEFITS OF WORKING FOR HONEYWELL** In addition to a performance-driven salary, cutting-edge work, and developing solutions side-by-side with dedicated experts in their fields, Honeywell employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance; Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance; Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and Paid Holidays. The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates. **Job Posting Date: December 5, 2025** **U.S. PERSON REQUIREMENTS** _Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. citizen, U.S. permanent resident, or have asylum or refugee status in the U.S._ **ABOUT HONEYWELL** Honeywell International Inc. (Nasdaq: HON) invents and commercializes technologies that address some of the world's most critical demands around energy, safety, security, air travel, productivity, and global urbanization. We are a leading software-industrial company dedicated to introducing state-of-the-art technology solutions to improve efficiency, productivity, sustainability, and safety in high-growth businesses in broad-based, attractive industrial end markets. Our products and solutions enable a safer, more comfortable, and more productive world, enhancing the quality of life of people around the globe. **THE BUSINESS UNIT** Honeywell Aerospace Technologies (AT) products and services are found on virtually every commercial, defense, and space aircraft in the world. We build aircraft engines, cockpit and cabin electronics, wireless connectivity systems, mechanical components, and more, and connect many of them via our high-speed Wi-Fi offerings. Our solutions create healthier air travel, more fuel-efficient and better-maintained aircraft, more direct and on-time flight arrivals, safer skies and airports, and more comfortable flights, along with several innovations and services that reflect exciting and emerging new transportation methods such as autonomous and supersonic flight. Revenues in 2023 for Honeywell Aerospace Technology were $14B and there are approximately 21,000 employees globally. Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, care or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status. Honeywell helps organizations solve the world's most complex challenges in automation, the future of aviation and energy transition. As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable. Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

Job Description PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. Job required Qualification: Bachelor of Science degree, Engineering, or Equivalent training and experience. More than 5 years of experience in a regulated environment. 3 years of experience authorizing procedural and commercial marketing documents. More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture. Experience in mechanic and Industrial engineering Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.) Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills. Strong relationship management, leadership, and organizational skills. Strong working knowledge in Microsoft suites, and Smartsheet. Job responsibilities and Duties: Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations. Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable). Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment. Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities. Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis. Investigate and resolve deviations/exceptions from the predefined acceptance criteria. Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid. Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies. Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner. Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure. Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs. Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed. Adhere to all cGMPs, compliance/regulatory mandates and quality requirements. Perform other related duties as assigned to meet departmental and Company objectives.

For Validation services in the Manufacturing areas. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Experience in: FDA, OSHA, EPA, GMPs, ISO requirements, and regulatory guidelines (GAMP 5, FDA). Computer Systems Validation Life Cycle, including generating Validation Plans, URS, FRS, SDS, traceability matrix, and protocols (IQ/OQ/PQ). Verification and validation processes, risk assessments, statistical analysis, and Lean/Six Sigma methodologies. Project Management and Technical Documentation 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develop and implement documentation, procedures, and training for engineering and validation activities. Participate in the Validation Life Cycle: review documentation, define requirements, perform risk assessments, and manage deviations. Generate and execute validation plans, protocols (FAT/SAT/IQ/OQ/PQ), and completion reports. Perform statistical analysis and develop sampling plans for testing and inspections. Review and approve validations for new and existing computer and automation systems. Manage installation of equipment and software modifications, including vendor coordination and troubleshooting. Lead process improvement projects and oversee validation contractor resources. Prepare metrics and reports for Quality Management Reviews and Operational Reviews. Ensure compliance with regulatory agencies and participate in audits (FDA, ISO, Notified Body). Investigate and document non-conformances, CAPAs, and prepare investigation 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 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

As a Mechanical Design Engineer I at Honeywell, you will impact the development of cutting-edge mechanical systems and components, collaborating with cross-functional teams to define requirements and specifications that enhance overall product performance. You will report directly to our Sr Engineering Manager, and you will work out of our Aguadilla, Puerto Rico location. At Honeywell, our people leaders play a critical role in developing and supporting our employees to help them perform at their best and drive change across the company. Help to build a strong, diverse team by recruiting talent, identifying, and developing successors, driving retention and engagement, and fostering an inclusive culture. Key Responsibilities: Design and develop mechanical systems, components, and assemblies from concept to production. Collaborate with cross-functional teams to define mechanical requirements and specifications. Perform mechanical analysis and simulations to ensure product performance and reliability. Travel, up to 50% may be required. Qualifications YOU MUST HAVE: Bachelor's degree from an accredited institution in a technical discipline such as the sciences, technology, engineering or mathematics 1 plus years of experience in mechanical design and development. Strong knowledge of mechanical design principles and methodologies. 1 plus years of experience with CAD software and other design tools. Experience with mechanical analysis and simulation tools. Be able to read, write and speak English. WE VALUE: Possess strong written and verbal communication skills, as the position demands the ability to represent the site in technical discussions with customers and/or regulatory agencies Advanced Engineering degrees like ME (Mechanical Engineering). Experience in aerospace or related industries. Understanding of industry standards and best practices. Knowledge of materials and manufacturing processes BENEFITS OF WORKING FOR HONEYWELL In addition to a performance-driven salary, cutting-edge work, and developing solutions side-by-side with dedicated experts in their fields, Honeywell employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance; Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance; Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and Paid Holidays. The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates. Job Posting Date: December 5, 2025 U.S. PERSON REQUIREMENTS Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. citizen, U.S. permanent resident, or have asylum or refugee status in the U.S. ABOUT HONEYWELL Honeywell International Inc. (Nasdaq: HON) invents and commercializes technologies that address some of the world's most critical demands around energy, safety, security, air travel, productivity, and global urbanization. We are a leading software-industrial company dedicated to introducing state-of-the-art technology solutions to improve efficiency, productivity, sustainability, and safety in high-growth businesses in broad-based, attractive industrial end markets. Our products and solutions enable a safer, more comfortable, and more productive world, enhancing the quality of life of people around the globe. THE BUSINESS UNIT Honeywell Aerospace Technologies (AT) products and services are found on virtually every commercial, defense, and space aircraft in the world. We build aircraft engines, cockpit and cabin electronics, wireless connectivity systems, mechanical components, and more, and connect many of them via our high-speed Wi-Fi offerings. Our solutions create healthier air travel, more fuel-efficient and better-maintained aircraft, more direct and on-time flight arrivals, safer skies and airports, and more comfortable flights, along with several innovations and services that reflect exciting and emerging new transportation methods such as autonomous and supersonic flight. Revenues in 2023 for Honeywell Aerospace Technology were $14B and there are approximately 21,000 employees globally. Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, care or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Jr. Validation Engineer Qualifications: Bachelor's Degree in Engineering. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.

For Validation support services in the Manufacturing & Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Life Sciences or Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry. Shift: Administrative & according to business needs Bilingual: (Spanish and English) Experience in: Minimum of 1 year of experience working in regulated environments Strong Technical Writing Skills Develop documents as procedures, forms, and change controls 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Knowledge of validation methodologies (IQ, OQ, PQ) and protocols. Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements. Proficient in using data analysis tools (Excel, Minitab, or equivalent). Excellent technical writing and documentation skills. Willingness to work in cleanroom or controlled environments. Knowledge of safety procedures and compliance with EHS regulations. Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements. Ensure that all new and existing protocols are effectively integrated into manufacturing processes. Ensure documentation is thorough, accurate and entered on a timely basis into the quality system. Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing. Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements. 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?