Quality engineer jobs in Puerto Rico - 191 jobs

Corp. Ultimate Solutions Corp. is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide. Position Summary The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test method validations, documentation review and approval, and support of quality investigations and CAPAs. The candidate will apply Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications. Responsibilities Execute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports. Perform and support test method validations to ensure compliance with intended use and regulatory requirements. Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation. Support the development, execution, and effectiveness verification of CAPAs. Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures. Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements. Develop, implement, and maintain Sampling Plans based on risk and statistical rationale. Support and execute Change Control activities, including impact assessments and cross-functional coordination. Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks. Ensure compliance with GMP, ISO, and applicable regulatory requirements. Education Bachelor's degree in Engineering or Sciences. 3-5 years of relevant experience in a regulated industry. Requirements / Skills Required experience in the Medical Device or Pharmaceutical industry. Strong knowledge and practical experience with GMP and ISO standards. Strong computer skills, including proficiency with MS Office applications (Word, Excel, Outlook) and MS Project Management tools. Solid knowledge of statistics, problem-solving methodologies, and Lean tools. Ability to work effectively in a team-based environment. Demonstrated ability to be a team player, self-starter, persistent, tactful, and persuasive. Strong organizational skills, attention to detail, analytical thinking, and accuracy. Effective verbal and written communication skills, including technical writing and presentations. Ability to work with minimal or no supervision. Fully bilingual in English and Spanish. Ultimate Solutions Corp. is an Equal Opportunity Employer.

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

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: Process Engineer - Biotech Plant Provides technical and operational support for fermentation manufacturing processes, ensuring that production operations run smoothly, safely, and in compliance with regulatory standards. Responsibilities include troubleshooting, documentation, process improvement, and equipment support. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in biotechnology industries. Experience in direct process / manufacturing areas. Apply basic scientific and engineering principles to support fermentation manufacturing processes. Translate operational requirements (e.g., SOPs, process flows) into practical field execution. Prepare or review and revise operational instructions. Provide technical support to resolve issues and implement corrective actions. Perform and support fermentation process activities Understand how equipment affects key process parameters and operational control strategy. Lead or support investigations, CAPAs, and change controls. Provide technical expertise and support validation activities when required. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and\/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigation. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Other duties may be assigned. Requirements Minimum 4 years of relevant experience within the regulated industry. Experience in Investigation and root cause analysis. Knowledge in Process Validation, Computer System Validation and Technical Writing. Bilingual. Bachelor Degree in Engineering or Science Completed. Willing to work 100% on site and weekend or overtime when needed. "}}],"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":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Sr Quality Systems Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015976001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26gCial6RtckyxSOPdzrQGXM\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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 Process Development Engineer. 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. * Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met. * Familiarity with equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/Sensors), etc. * Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data to draw meaningful conclusions. * Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes that are being developed. * Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize the risks. Also, work with PFMEA methodology for risk analysis documentation.

The Manufacturing Engineer is responsible for designing, developing, validating, and sustaining manufacturing processes, equipment, and systems to ensure efficient, compliant, and high-quality production. This role functions as an established individual contributor, supporting moderately complex projects and cross-functional initiatives within a regulated manufacturing environment. Key Responsibilities Responsibilities may include the following and other duties may be assigned: Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations. Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance. Adapt machine and equipment designs to meet factory and production conditions. Incorporate inspection and testing requirements into production and validation plans. Perform process and equipment performance evaluations to verify efficiency, capability, and compliance. Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality. Provide technical and sustaining engineering support to manufacturing operations. Develop and support manufacturing processes applicable to Statistical Process Control (SPC). Apply statistical techniques to analyze process performance and drive continuous improvement. Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements. Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities. Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques. Participate in cross-functional meetings and project teams to meet operational and project objectives. Support project scheduling and execution to ensure deadlines are met without operational impact. May mentor or provide guidance to entry-level engineers or support personnel. Requirements: Education Bachelor's degree required in Engineering Minimum of 2 years of relevant manufacturing engineering experience in the regulated industry. Technical Knowledge & Skills Knowledge of Process Validation, Equipment IQ, and Computer Software Validation Experience conducting investigations and root cause analysis in manufacturing environments Knowledge of statistical techniques and Statistical Process Control (SPC) Ability to evaluate machinery, equipment, and tools to verify performance and efficiency Experience supporting technical and sustaining engineering activities Work Methodology: 100% On-Site in Villalba, PR Full time job Professional services job classification Administrative shift from Monday to Friday (8am-5pm) 6 months of 1st contract up to 2 years based on performance and budget

Responsible for accessing the processes productivity challenges, generate and execute solutions following the procedures of and quality regulations of the client to assure improvement and sustainability of the results. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Assist process development activities. Performs root\-cause analysis, define and implement corrective\/preventive actions. Mitigate product failures at all stages of the client's manufacturing process. Identifies opportunities or the need for equipment, material or process changes or improvements. Provides product design reviews and feedback for manufacturability guidance. Responsible for developing process documentation and training materials for new processes, materials, and equipment process engineering and controls support. Requirements BS Degree in Engineering. One (1)) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- Proven experience working with Six Sigma\/Process Excellence Tools and Methodologies (i.e. DMAIC, Lean Manufacturing, Process Mapping, Cause & Effect, FMEA, DOE) "}}],"is Mobile":false,"iframe":"true","job Type":"Contrato","apply Name":"Apply Now","zsoid":"664728484","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Biotecnologà a"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"San Juan"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Process Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054422","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjgR1jtT5bfyqzaBW1rb2Ruw\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

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?

A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr

**_What Industrial Engineering contributes to Cardinal Health_** Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Industrial Engineering is responsible for enhancing / developing processes, layout and associated tools. Identifies, analyzes and implements new or existing technology to optimize business processes. Designs process improvements to reduce cost, cycle time, improve quality and/or increase throughput. Directs external resources / contractors as required. The Principal Industrial Engineer supports Pharmaceutical Supply Chain Operations in the areas of capital project planning and management, capacity planning, operational process change, and overall distribution center operating layout optimization. The position will also support deployment of new process and automation solutions, facilitate new building designs and layouts changes. Additional responsibilities include partnering with Operations leaders, deploying capital project investments for Pharma Supply Chain Operations, and overseeing project implementation and adoption to realize improvements. **_Responsibilities_** + Drive process engineering initiatives including conceptual operational designs, layout-change scenarios, and innovative automation solutions. Work closely with business operations partners to iterate on solutioning to optimize results. Bring modernization concepts to Operations through material handling and engineering external partnerships. + Works closely with Pharmaceutical Supply Chain Operations Vice Presidents, and site leaders to manage capital projects planned within the buildings. Develops capital budget priorities, establishes preliminary budgets,business case justifications, and formalizes all capital requests for budgeted, approved, or newly scoped projects. + Leads multifunctional teams of stakeholders and contributors to deliver large complex projects on time and under budget.Coordinates with other functional groups including Corporate Real Estate,field operations, Security, Information Technology, Inventory, Quality & Regulatory, Sales,and EH&S to ensure efforts are aligned, and coordinated as projects are developed and analyzed. + Integrated team members supporting operations leadership teams to ensure that capital projects and infrastructure are deployed, coordinated, managed, and maintained to drive building performance expectations. This role also manages and executes small construction projects independent of Corporate Real Estate / Construction including all cage and vault construction resulting from expansion or relocation needs. **_Qualifications_** + Bachelor's Degree in related field or relevant work experience, preferred + 4-6 years of experience in Operations, project and budgetary management, capital investment analysis and deployment, leading complex projects with multi-functional teams, preferred + Experience with automation solutions, facility design, material handling systems, integrated warehouse controls and execution applications, preferred + Experience with AutoCAD and other software applications to drive warehouse design and concepting, preferred + Strong Leadership skills, Strong scheduling and organizational skills + Excellent technical problem-solving capability + High level of initiative - Team player + Willing and transparent communicator + Proficient with Microsoft Office Suite + Excellent written and verbal communication skills + Moderate travel to other facilities for projects and supervision of equipment installation (25%, up to 50% during specific deployment activities and project implementations) **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 3/13/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

Provides technical and engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and\/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling \/ fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Deep knowledge of the validation lifecycle. *Other duties may be assigned. Requirements Minimum 2 years of experience working with Validation in a regulated industry. Experience in equipment troubleshooting, process and Root Cause Analysis. Bachelor Degree in Engineering Completed. Presentation and Teamwork skills. Fully Bilingual. "}}],"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":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Ponce"},{"field Label":"State\/Province","uitype":1,"value":"Ponce"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00716"}],"header Name":"Process Engineer I","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015799001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26lFMfUSOIQn@v.4i65P0snE\-&embedsource=Google","location":"Ponce","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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.

We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts. Project: 6 new manufacturing lines for a medical devices company in Juncos-PR Responsibilities: This role is focused on building, validating, and enabling manufacturing processes. Generate and execute validation protocols. Perform process characterization activities. Manufacturing process development. Strong candidates will demonstrate a proactive, preventive mindset, with experience establishing process capability, supporting manufacturing readiness, and working closely with MS&T or Tech Ops functions. The emphasis for this position is on upfront process design, validation execution, and ensuring processes are robust, scalable, and production-ready. Requirements: Education: Bachelor´s degree in Engineering (Mechanical, Electrical, Chemical, etc.) 2 to 5 years of minimum experience Experienced with medical devices products Process Validation (PV): characterization, OQ, PQ (non-cleaning) Equipment Qualification (CSV): URS, FAT, IQ, OQ, PQ, TMV (non-lab) Validation strategies & requirements flow-down (design → manufacturing) Risk management documentation (pFMEA) Basic statistics (Minitab preferred) Design transfer activities Design requirements validation & manufacturing controls Project-based validation experience Work Methodology: Full time special project assignment Full on-site job in Juncos, PR 5 months of special project contract Shift: Administrative and wiling to support non-standard shifts based on project needs Availability to start this work on February 1st, 2026

For Validation services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree and or an equivalent of three (3) years of experience in Industrial and Construction projects within the regulated industry. Bilingual (Spanish and English). Good organizational and problem-solving skills. Shift: First (Monday-Friday) & according to business needs. Experience in: Process Validation and Development. FDA, GMP, and ISO guidelines. Statistical techniques (DOE, SPC). Computer software knowledge (Microsoft Word, Excel, Power Point). The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develops, manages, and executes cost improvement, product/process, and technology transfer projects. Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters. Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities. Conduct process equipment installation/operational/performance qualification studies to test their functionality . Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment. Other duties as assigned. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

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: Process Engineer - Biotech Plant Provides technical and operational support for fermentation manufacturing processes, ensuring that production operations run smoothly, safely, and in compliance with regulatory standards. Responsibilities include troubleshooting, documentation, process improvement, and equipment support. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in biotechnology industries. Experience in direct process / manufacturing areas. Apply basic scientific and engineering principles to support fermentation manufacturing processes. Translate operational requirements (e.g., SOPs, process flows) into practical field execution. Prepare or review and revise operational instructions. Provide technical support to resolve issues and implement corrective actions. Perform and support fermentation process activities Understand how equipment affects key process parameters and operational control strategy. Lead or support investigations, CAPAs, and change controls. Provide technical expertise and support validation activities when required. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.

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: We are seeking a Process Engineer with strong experience in validations, including Master Validation Plans, IQ, OQ, MSA, PQ, and related activities. The candidate must be fully bilingual and have at least two years of experience in validation within a medical device company. Validation lifecycle knowledge / Hands on experience (Writing and executing IQ/OQ/PQ protocols among others) Troubleshooting equipment / process failures Analyzing test data and statistical trends Qualifications Requirements/Knowledge/Education/Skills: BBA in Enigneering At least two years of hands-on experience in validations within the medical device industry. 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.

Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and\/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. ***Other duties may be assigned.*** Requirements Minimum 4 years of experience in the regulated industry, preferably in Medical Devices. Experience in Change control of Medical Devices, Equipment Commissioning \/ Qualification, Process Validation, CSV, Manufacturing, Packaging and Laboratory Equipment. Technical (Troubleshooting), Quality, Process Control and Assurance. Bilingual. Bachelor Degree in Engineering completed. Willing to work 100% on\-site in Juncos, PR. Top 3 things you are looking for in a candidates experience: Proficient in validation process, CSV, PV Proficient in Troubleshooting, Equipment Setups Proficient in document management "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Engineering"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016933001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26sJb6@sa8AAn7A.ZodxIbkI\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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: Process Engineer Experience in Process Engineering for the Medical Device Industry Experience in Qualifications Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in regulatory guidance Experience with Process Engineering and the development and execution of Validation Protocols Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.

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?