Quality engineer jobs in Bayamn, PR

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **MANAGER QA - DRUG SUBSTANCE OPS (NIGHT SHIFT)** **What you will do** Let's do this. Let's change the world! In this vital role in support to Amgen's Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift). **Specific responsibilities include but are not limited to:** + Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management. + Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations. + Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards. + Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays. + Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents. + Represent QA in New Product Introduction (NPI) teams and during audits and inspections. + Lead investigations and plant audits; approve change-over completion activities. + Ensure deviations are properly investigated and documented; verify accuracy and completeness of production records and test results. + Collaborate cross-functionally to ensure QMS processes follow established procedures. + Bring up quality, compliance, supply, and safety risks to senior management. + Ensure controlled documents have assigned owners and that periodic reviews are completed on time. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The Manager QA professional we seek is a strong leader with these qualifications. **Basic Qualifications:** Doctorate degree Or Master's degree and 3 years of experience in regulated industry experience Or Bachelor's degree and 5 years of experience in regulated industry experience Or Associate's degree and 10 years of experience in regulated industry experience Or High school diploma / GED and 12 years of experience in regulated industry experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above **Preferred Qualifications:** + Educational background in Life Sciences or Engineering + Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development. + Validated expertise in Quality Systems such as Deviations, CAPA and Change Control + Experience leading cross functional teams with the influencing and negotiating skills + Strong organizational, project management and change management skills + Strong communication skills (both written and oral), and comprehend in English and Spanish + Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads. + Ability to interact with regulatory agencies **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans and an annual site shutdown + Flexible work models, including remote work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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

For Engineer services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Sciences and over eight (8) years of exposure within the Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Excellent Communication skills, and Positive attitude. Shift: 1st Shift Experience in: Quality Systems, including CAPA, Change Control, and Validations Medical Device Regulatory Requirements and compliance standards Quality and Regulatory Audit activities, including preparation, execution, and follow-up The Personality Part: Our Next Piece is someone who leads with empathy, communicates with clarity, and thrives in complex, collaborative environments. They coach others, solve problems creatively, and make a meaningful impact through trust and initiative. 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) Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Work directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet guidelines. Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages. Coordinate legal requests in support of government investigations or litigations. Ensure the quality assurance programs and policies are maintained and modified regularly. Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves on 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?

Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and industry standards. Ensure the performance and quality of services conform to established Quality System standards, agency guidelines, and company expectations. Offer expertise and guidance in interpreting regulatory, governmental, and internal quality policies to maintain compliance across operations. Partner with operating entities to analyze processes, ensure requirement alignment, and drive continuous improvement initiatives. Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings. Act as liaison with internal\/external auditing groups and regulatory inspectors throughout the entire audit lifecycle. Coordinate legal and quality documentation requests in support of government investigations or litigations. Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards and regulatory expectations. Promote uniform global quality standards and facilitate best\-practice sharing across sites and teams. Other duties may be assigned. Requirements Minimum of 4 years of relevant experience in the regulated industry. Top 3 Required Experience Areas: Strong investigation skills with demonstrated root cause analysis capabilities. Proficient technical writing, strong organization, and effective communication skills. Experience in Process Validation and Computer Software Validation (CSV). Bachelor's Degree completed with a minimum of 4 years of relevant experience. Master's degree with a minimum of 2 years of relevant experience. *Willing to work 100% on\-Site in Juncos,PR.* "}}],"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":"Puerto Rico"},{"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":"118922000017233003","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26ksH07zDXwNYrxh4J3I3qZA\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications. • Reviews and analyzes quality trends with the manufacturing team. • Considering the quality trends provides directions in terms of setting work priorities for process enhancement. • Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented. • Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it. • Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process. • Analyzes data based on trends, recommends actions for process, equipment and system improvement. • Writes procedures, protocols and any other documentation needed for the enhancement of systems. • Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. • Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions. • Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. • Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. • Drives SPC or preventive action methods. • Reviews and approves qualification / validation reports, ECO's/CA's, process changes, quality records or manufacturing documentation. • Implements quality system improvements. • Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits. • Integrates Quality Systems Regulations into New Product & Technology Development.  Performs other position duties as assigned.

GENERAL DESCRIPTION: Coordinates appointments and services, and supports all initiatives related to quality documents. Provides support to the entire Quality Department by preparing documents and reviewing information to comply with the different regulations and policies and procedures. ESSENTIAL FUNCTIONS: Performs data entry, and review of documents, formats, forms, and/or information related to the Department. Coordinates and ensures constant and effective communication with other company departments for the intervention and/or requests for information required to support the completion of projects and/or activities related to the department, according to operational need. Coordinates the planning of the Quality Department's meetings as required. Keeps track of standards, documentation, binders, and applications in preparation for audits and Administrative Quality processes. Maintains the supervisor informed of the status of tasks related to Quality projects to keep them notified of the progress of these projects. Supports different administrative tasks related to the Model of Care, AAAHC accreditation and other projects, as needed. Performs presentations for the Administrative Quality initiatives as required. Digitalize documents and different information in the corresponding Administrative Quality folders. Keeps electronic files organized and in the required formats to present and use as reference as required. Maintains records, documentation, and folders for each project, request, and/or special event to be used as reference. Receives, answers, and effectively forwards calls and/or requests received in the department and monitors for resolution in cases that merit it. Supports the submission of reports required by regulatory agencies promptly and as requested (ASES, CMS, Other Departments) among others. Validates and determines the procedures to be conducted to refer requests to the corresponding areas, maintains a record of said procedures, and provides follow-up. ADDITIONAL FUNCTIONS: Must comply fully and consistently with all company policies and procedures, with local and federal laws as well as with the regulations applicable to our Industry, to maintain appropriate business and employment practices. May carry out other duties and responsibilities as assigned, according to the requirements of education and experience contained in this document. MINIMUM QUALIFICIATIONS: Education and Experience: Associate's degree, preferably in Business Administration, Management, Accounting, or related areas. At least one (1) year of experience performing administrative and coordination tasks. "Proven experience may be replaced by previously established requirements." Certifications / Licenses: N/A Other: N/A Languages: Spanish-Advanced (writing, reading, and conversational) English-Advanced (writing, reading, and conversational) Job Type: Full-time Salary: From $13.00 per hour Expected hours: 38.5 per week Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

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.

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: * Manufacturing Engineer / Validation Specialist Job Summary: We are seeking a detail-oriented Manufacturing Engineer / Validation Specialist to join our team. The ideal candidate will be responsible for designing, implementing, and maintaining manufacturing processes in compliance with regulatory standards. Additionally, this role will involve validating equipment and processes to ensure efficiency and quality in our manufacturing operations. Qualifications: * Bachelor's degree in Engineering. * 2-5 years Equipment and Process Validation experience. * Proven experience in manufacturing engineering and validation processes. * Familiarity with regulatory requirements in the manufacturing industry. * Strong analytical and problem-solving skills. * Excellent communication and teamwork abilities. Responsibilities: * Develop and maintain manufacturing processes, procedures, and documentation. * Coordinate and execute validation activities for manufacturing equipment and processes. * Ensure compliance with regulatory standards and best practices. * Identify areas for process improvement and implement solutions. * Collaborate with cross-functional teams to drive efficiency and quality in manufacturing operations. Preferred Qualifications: * Certification in Lean Six Sigma or other process improvement methodologies. * Experience working with Molding and Laser equipment. * Knowledge of risk management principles in manufacturing.

We are seeking a highly motivated and detail-oriented Manufacturing/Validation Specialist. The ideal candidate will be responsible for performing equipment qualification and process validation activities. Qualifications and educational background: Bachelor's degree in engineering (required) 2-5 years in Equipment and Process Validation. Preferred focus: Molding and Laser equipment Proven track record supporting manufacturing lines Skilled in applying problem-solving techniques to improve process yield Strong background in equipment troubleshooting Bilingual (Spanish and English)

The Quality Technician will assist in the execution and documentation of quality control activities, focusing on inspection processes, document review, and support for manufacturing area(s). Responsibilities: Review production documentation per batches. Assist in the revision of incoming inspection documentation. Perform quality checks on assembly and inspection lines using established techniques. Document inspection results and escalate non-conformances. Maintain compliance with internal procedures and regulatory requirements. Apply regulatory compliance and quality practices in a regulated manufacturing work environment. Other assigned duties, as assigned. Qualifications: Bachelor´s degree in Science, Administration, Engineering, or related field. Minimum of 3 years of experience in quality assurance for manufacturing industries. Familiarity with validation documentation and inspection protocols. Detail-oriented with strong documentation and communication skills. Bilingual (English/Spanish) preferred. Work Methodology: 100% On-site and Full-time project 13 months (1st Contract) Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need). Professional services contract

Job description: Smart Precise Solutions, Inc . is a consulting firm that mainly focuses on engineering-related projects. We are looking for an industrial engineer to be responsible for all engineering and technical disciplines that projects involve. Main Responsibilities: a) Directs time and motion studies to identify opportunities to improve overall efficiency and cost savings relative to employees and facilities. b) Conducts or leads in the observation and analysis of work procedures to determine the time and motion requirements of each position or assignment. c) Analyzes data and specifications to establish reasonable time and production standards. d) Uses mathematical analysis to identify objective measurements of alternate work patterns. e) Applies industrial management techniques and principles to develop cost and time-saving recommendations and modifications to work methods, staffing requirements, wage rates, and equipment and facilities upgrades. f) Promote LEAN manufacturing practices and implementation. g) Designs and coordinates all phases of the production process using industrial engineering principles and best practices. h) Manage process documentation (work instructions and visual aids). i) Develop and implement process improvements and technological upgrades. j) Performs other related duties as assigned. Education: Engineering bachelor's degree and/or master's degree in Industrial Engineering Experience: 3 to 5 years' experience in Medical Devices, Pharmaceutical, or Biotechnology Industry with strong knowledge in Standard Works and Time Study (preferred). Required Skills: Strong written and verbal skills in both English and Spanish, presentation skills, ability to write concise engineering documentation, self-starter, strong teamwork abilities. Knowledge in MS Office 365 (Word, PowerPoint, and Excel). Ability to work with multiple discipline projects Project management and supervision skills Decision-making ability and leadership skills Time management and organization skills Licenses: Engineer in Training License (EIT) or Professional Engineer, PE (preferred) Smart Precise Solutions, LLC is an Equal Opportunity Employer. Smart Precise Solutions, LLC and all its divisions, subsidiaries, and affiliates hereby reaffirm the Company's policy of non-discrimination in all aspects of the business. Job Type: Full-time Benefits: Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Vision insurance Schedule: Day shift Monday to Friday Education: Bachelor's (Required) Experience: Time management: 2 years (Preferred) Language: English (Required) Work Location: In person

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

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.

EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ). We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service. We are seeking an Industrial Engineer to join our team in a Medical Device Manufacturing environment, supporting initiatives that drive continuous improvement and operational excellence on the production floor. Requirements Bachelor's degree in Industrial Engineering 2+ years of experience in continuous improvement within manufacturing Strong knowledge of lean manufacturing concepts and transformation initiatives Experience in time studies and line rebalancing Proficiency with CAD-based layouts Cost analysis and project management experience Fully bilingual (English/Spanish) Responsibilities Support the Flow Acceleration Program, eliminating waste, streamlining material and information flow, and fostering continuous improvement in cleanroom operations Implement and sustain Lean Manufacturing concepts across processes Drive process optimization initiatives to improve efficiency and productivity Analyze data and metrics to measure performance and identify opportunities for improvement Develop and implement standardized procedures for enhanced consistency and quality Collaborate cross-functionally with engineering, quality, and operations teams Apply strong problem-solving skills to address production challenges Support equipment optimization and layout design using CAD tools Manage and execute improvement projects from initiation to completion Work Details Location: On-site, Villalba, PR (full-time) Schedule: 1st shift On-site role - Applicants must currently reside in Puerto Rico Job Types: Full-time Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance

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: Analyses and designs sequence of operations and workflow to improve efficiencies in plant and production facilities and equipment layouts; and establishes methods for maximum utilization of production facilities and personnel. May establish or assist in establishing accident prevention measures and may manage training programs for personnel concerning all phases of production operations. Conducts studies pertaining to cost control, cost reduction, inventory control, and production record systems. On the basis of these studies, develops and implements plans and programs for facility modifications and revisions to operating methods. May assist facilities engineers in the planning and design of facilities. Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Qualifications: Bachelor's degree in Industrial Engineering 2+ years of relevant experience Experience with agile, lean manufacturing concepts and transformations Experience in cost analysis Project management and analytical problem-solving skills Knowledge in conducting time studies and applying line balancing techniques to improve efficiency, reduce cycle times, and minimize waste. Knowledge in CAD layouts to support space utilization, product segregation and the analysis and optimization of material flow. Knowledge in Flow Acceleration Program Continuous improvement mindset Fully bilingual (English/Spanish) Available for 1st shift (40 hours per week) 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.

At Winchester Interconnect, we always do the right thing, the right way. Winchester Interconnect is committed to inspiring the most innovative teams. We foster a dynamic and inclusive environment that thrives on collaboration and continuous growth. We hire exceptional people, celebrate achievements, drive employee growth, and provide opportunities to thrive. Winchester is where potential becomes purpose, and every team member plays a vital role in building our shared success. Job Summary: As our Lean Manufacturing Engineer you will be a key change agent, responsible for analyzing, designing, and implementing lean manufacturing processes. Your primary mission will be to identify and eliminate waste, optimize workflow, and improve overall efficiency in our electronics manufacturing operations, fostering a culture of continuous improvement throughout the organization. Qualifications and requirements: Bachelor's degree in Industrial, Mechanical, Manufacturing Engineering, or a related technical field. 3 to 5 years of proven experience applying lean manufacturing methodologies in a manufacturing environment, preferably in the electronics or aerospace industry. Lean Six Sigma Certification (Green Belt or Black Belt) is highly desirable. Mastery in the application of Lean tools such as Value Stream Mapping (VSM), Kaizen, 5S, Poka-Yoke and Kanban. Speak and write both English and Spanish. Strong analytical, problem-solving, and project management skills. Knowledge of ISO9000 and AS9100 quality standards. Proficiency in Microsoft Office (Excel, Word, Access, etc.) and statistical analysis software (e.g., Minitab). Our core values Responsibility, Collaboration, and Empowerment (ACE) are the foundation of our operation and drive success. You will assume the Responsibility for the analysis of production processes to identify opportunities and will be responsible for the measurable results of its improvement initiatives. Collaborate closely with the production team, engineers, and quality staff to implement effective changes and ensure that Lean solutions are aligned with operational objectives. Empowered to challenge the status quo, lead Kaizen events, and empower teams, giving them the tools to drive continuous improvement in their own work areas. Will you be our next ACE? You will be responsible for designing and implementing lean manufacturing projects to improve safety, quality, delivery, and cost. This includes creating value stream maps, facilitating kaizen events, and implementing visual management systems on the shop floor. Finally, you will develop and monitor key performance indicators (KPIs) to measure the effectiveness of improvements, train staff in lean principles and tools, and act as a mentor to foster a continuous improvement mindset throughout the operation. Systems you will use: Google Enterprise ADP ERP Statistical analysis and process mapping software (Minitab, Visio) To get a sneak peek at some of our benefits and learn more about our career opportunities, click here ****************************** Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. In addition to the requirements of federal law, Winchester Interconnect complies with applicable state and local laws governing employment nondiscrimination in all locations where the company has facilities. Winchester Interconnect expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. ***Candidate inquiries only - No third parties accepted***

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

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

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: Established and productive individual contributor that works independently with general supervision on larger, moderately complex projects / assignments. Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones and may have some involvement in cross functional assignments. Communicates primarily and frequently with internal contacts and with the 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 decision-making. 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 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: Mechanical, Chemical, Electrical Engineering Preferred Qualifications: Collaboration and Teamwork with adaptability project tasks requirements. Communication skills (English / Spanish) Problem-Solving Skill and Continuous Improvement Mindset Attention to details Skills: Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. 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 CompaniesAffiliated Companies: Echo Consulting Group Inc