Process engineer jobs in Guaynabo, PR - 122 jobs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Process Engineering function is part of the Maintenance and Engineering Department that provides technical expertise and support to Dry Product Operations (DPO) ensuring compliance with cGMP, HSE guidelines and regulations, company standards and business practices. The primary areas of support include technical expertise (process and equipment), manufacturing and business process improvements, compliance with business systems, and people development. DPO technologies/processes include Wet Granulation; Roller Compaction; Tablet Compression/Coating/Inspection/Printing; Direct Compression Continuous Manufacturing; Pellet Coating and Capsule Filling/Inspection. Responsibilities: Provide DPO expertise as equipment/asset steward for the area he/she supports to maintain an efficient manufacturing processes. Establish and maintain technical information of the process and unit operations within the manufacturing process. Develop and monitor process and capacity indicators to identify and address performance issues and identify improvement opportunities. Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs). Perform troubleshooting and investigation on unexpected issues. Own equipment related deviations, CAPAs and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality, safety, environmental events. Provide technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities. Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modeling. Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub teams. Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety. Requirements: Bachelor's degree in Engineering (Chemical or Mechanical) 5+ years of experience in pharma manufacturing operations Candidates with less than 5 years of experience in pharma manufacturing can be considered and salary will be commensurate to experience EIT license required, as a minimum (member of CIAPR) Bilingual (English/Spanish) with strong written and oral communication skills Strong leadership and organizational skills Sound judgment Teamwork oriented; ability to work cross functionally Knowledge in managing multiple project objectives or assignments Technical Writing Strong customer service focus Additional Information: Available to work or provide support to a 24/7 operation, if necessary Availability to travel within and outside Puerto Rico and U.S. Work as a resource in other strategic areas of the business Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $52,500 - $154,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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"}

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 - 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.

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

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

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 Senior Casting Technology Manufacturing Engineer provides technical leadership for SX or equiax investment castings across the value stream. You will partner with suppliers and cross-functional teams to drive root cause problem solving, improve producibility, increase productivity, and deliver on business objectives. You will own supplier technical relationships, coach on internal processes/specs/methods, qualify new suppliers, and help develop and industrialize alternate casting technologies. **Job Description** **Roles and Responsibilities** + Provide process and product technical leadership for the Castings commodity, including SX or equiax investment castings. + Develop strong working relationships with casting supplier technical teams. + Partner with suppliers to identify and implement corrective actions to eliminate the cause and prevent recurrence. + Act as a change agent to advance world-class performance and standard work across the supply base. + Own supplier technical relationships; mentor suppliers on GE Aerospace processes, specifications, and methods; ensure compliance and capability. + Lead cross-functional problem solving, to identify true root cause and implement sustainable corrective and preventive actions. + Improve manufacturability through design-for-casting, specification clarity, and process capability improvements. + Clearly communicate progress, risks, challenges, and countermeasures to leadership and stakeholders. + Review and approve significant/special processes; ensure adherence to standards and qualification requirements. + Collaborate with Quality and Design Engineering to ensure new and changed processes meet established metrics; align with other commodities on strategy and objectives + Partner with suppliers and internal teams to interpret drawings/specifications, ensuring conformance and clarity. + Identify and onboard new suppliers; lead technical qualifications and readiness through Manufacturing and Quality Planning reviews and support supplier Castings Audits. + Ability to travel to supplier sites 30%-50% **Minimum Required Qualifications** + Bachelor's degree in Engineering (Materials/Metallurgy, Mechanical, Manufacturing, or related field) + Minimum of 5 years of materials engineering, castings, mechanical engineering or a related field **Desired Characteristics and Experience** + Additive manufacturing experience. + Metal Injection Molding (MIM) experience. + Proficiency with Siemens NX or comparable CAD. + Sand Castings Experience. + Titanium Experience. + Significant experience in investment castings (SX or equiax), with demonstrated yield, capability, and cost improvements + Hands-on expertise across investment casting special processes (wax, shell, melt/solidification control, heat treat, HIP, NDT) and specification compliance. + Strong problem solving and project management skills. + New Product Introduction experience. + Experience maturing technologies and processes. + Excellent communication and stakeholder management; ability to influence without authority + Humble learner: Respectful, receptive to feedback, agile, and continuously improving; seeks out diverse perspectives. + Transparent communicator: Shares critical information proactively; speaks with candor; engages constructively to resolve issues. + Focused and accountable: Fast learner with strong ownership; meets commitments and drives results against SQDC targets ( _Safety, Quality, Delivery and Cost in that order)_ . **Pay and Benefits:** + The salary range for this position is $ 116,000.00 - 155,000.00. The specific salary offered to a candidate may be influenced by a variety of factors including the candidate's experience, their education, and the work location. In addition, this position is eligible for a performance bonus/variable incentive plan. + GE provides a comprehensive benefits package that provides access to plans which support the overall wellbeing of our employees and their dependents. These benefits include, but are not limited to, health care coverage (medical, dental, vision, pharmacy), a retirement plan that includes Company Retirement Savings and a 401K with Company matching, Life Insurance options, Disability coverage, paid time-off, EAP, and more. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach, a 24/7 nurse-based resource; and access to the Employee Assistance Program, providing 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Retirement Savings Plan, a tax-advantaged 401(k) savings opportunity with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. General Electric Company, Ropcor, Inc., their successors, and in some cases their affiliates, each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace, or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

For Engineering and Project Management services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Engineering (Preferred Mechanical, Electrical & Computer) & five (5) years of relevant experience within the Medical Devices or Pharmaceutical industry. Skills: Attention to details and verbal and written communication skills, Bilingual (Spanish & English). Shift: 1st and according to business needs. Experience in: Manufacturing line process and production. working with a revision control system, preferable Git & Gitlab MES Proficiency in R/SQL/BASH programming and Linux Integrate new and/or existing equipment/automation. The Personality Part: Our Next Piece 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards, improve production efficiencies, and manufacturing. 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. Develops manufacturing processes that apply to statistical process control and may develop those techniques, including the measurement systems. Ensures processes and procedures comply with regulations. 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?

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: * 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. Shift: 1st Shift Location: Villalba, PR Education: Bachelor's degree required in Engineering Preferred Qualifications: * Process Validation, Equipment IQ and Computer software validation knowledge * Technical writing knowledge and Communication skills * Investigation and root cause analysis skills Skills * 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. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Must have knowledge in Process Validation, Equipment IQ and Computer software validation. Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (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). Knowledgeable on statistical techniques. In addition, the resource needs to be schedule oriented in order to meet projects objectives and assignments without impacting deadlines and it is really important for the resource to have good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team. Qualifications: Bachelor's degree in Engineering Minimum of 2 years of relevant experience. Knowledge in Process Validation, Equipment IQ and Computer software validation. Investigation and root cause analysis skills Technical writing knowledge and Communication skills Shift: 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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

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. Responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards. This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air and HVAC. The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations. Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Requirements Minimum 5 years of experience in Utilities Equipment, Regulatory and Compliance Systems, Troubleshooting, Agile Systems, SAP Systems, Validation Qualification Phases and Commissioning. Bachelor or Technical Degree in Science or Engineering. Bilingual. Willing to work 100% on\-site in Villalba. What are the top 3 things you are looking for in a candidates experience: 1. Validation of facilities and utilities equipment including air compressor and HVAC system 2. FDA and ISO regulated industry experience 3. Operational SOP, validation protocols and maintenance plan "}}],"is Mobile":false,"iframe":"true","job Type":"Temporary","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":"villalba"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00766"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016593001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26iT6OuvU0tpqTzPsm4rsMQg\-&embedsource=Google","location":"villalba","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

Responsible for developing efficient systems, processes and machines that result in high\-quality products. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Evaluate manufacturing processes based on quality criteria, such as efficiency and speed Study production and machine requirements Develop and test effective automated and manual systems Design and install equipment Organize and manage manufacturing workflows and resources Integrate disparate systems (e.g. equipment handling, transport) Optimize facility layouts, production lines, machine operations and network performance Resolve issues and delays in production Find ways to reduce costs and maximize quality Train staff in new and existing processes Collaborate with other engineers, contractors and suppliers Ensure that manufacturing procedures follow safety and environmental regulations Upgrade systems and processes with new technology Requirements BS Degree in Engineering. Zero (0) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- \- Fully bilingual (English and Spanish). "}}],"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":"Industrial"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Manufacturing Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054208","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjj@wtbl46FVujroldHq3BqE\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

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.

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

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 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"}

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 Development Engineer 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: Process Validation 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 task. Process Development Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met. Familiarity with a variety of technologies and 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 these risks. Also work with PFMEA methodology for risk analysis documentation. Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively. Be able to effectively communicate technical concepts to a variety of audiences, both technical and non-technical, through reports, presentations, and other media. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3-5 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process / manufacturing areas. 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.