Quality engineer jobs in Vega Baja, PR - 191 jobs

The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. **Key Responsibilities** **Clinical Study Support** + Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. + Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. + Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle. **Inspection Readiness** + Support inspection readiness activities including mock audits, documentation reviews, and training coordination. + Maintain inspection readiness tools, trackers, and communication plans. + Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit plan using risk-based approaches. + Coordinate and support investigator site, vendor, and internal process audits. + Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs). + Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies. + Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities. + Stay current with evolving global GCP regulations and industry best practices. **Collaboration & Team Support** + Partner with internal stakeholders and CROs to ensure consistent quality oversight. + May mentor junior staff or contractors. + Contribute to cross-functional initiatives that promote a culture of quality and compliance. **Qualifications** Required + Bachelor's degree in life sciences or related field; advanced degree a plus. + 6-8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry. + Solid understanding of GCP, ICH guidelines, and global regulatory requirements. + Experience supporting inspection readiness and participating in audits or inspections. + Strong communication, organizational, and problem-solving skills. + Ability to travel domestically and internationally as needed. + Proficiency in MS Office (Word, Excel, PowerPoint). **Preferred:** + Experience with TrackWise or similar quality management systems. + Prior collaboration with CROs and external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

At INVID, we're looking for a skilled and experienced QA Manager to lead our quality assurance initiatives across web and mobile platforms. This is a key leadership role requiring deep expertise in software testing, managing QA teams, and designing automated testing pipelines. The ideal candidate excels in evaluating applications for performance, security, usability, accessibility, scalability, and reliability, leveraging both manual and regression testing methods. Beyond testing proficiency, the QA Manager will be responsible for building and mentoring QA/QC teams, recruiting top talent, conducting internal audits, and driving continuous improvement through well-defined QA metrics and SOPs. What sets INVID apart is our collaborative and flexible work environment. We encourage our team to raise the bar in everything they do while maintaining a healthy work-life balance. With our hybrid work model, team members thrive both in the office and remotely. We foster a culture of mutual respect, autonomy, and accountability, where your voice matters and your growth is supported. From structured career paths and paid professional development to access to industry events, we're committed to your success. Position Overview We are seeking a Quality Assurance (QA) Manager to lead and evolve our QA practice. This role is essential to ensuring the delivery of reliable, secure, and user-friendly software solutions across web and mobile platforms. The ideal candidate will bring deep expertise in modern testing methodologies, automation, and DevSecOps practices, along with strong leadership and strategic thinking. Key Responsibilities Lead and mentor a team of QA engineers and analysts across multiple projects. Design and implement comprehensive QA strategies that include: Functional Testing (manual and automated) Regression Testing Security Testing Accessibility & Usability Testing Performance & Load Testing Web and Mobile App Testing Promote and integrate DevSecOps principles into QA workflows. Collaborate with development, product, and operations teams to ensure quality throughout the SDLC. Drive adoption of CI/CD pipelines and automated testing frameworks. Define and track QA metrics to measure effectiveness and identify areas for improvement. Contribute to the Center of Excellence by standardizing QA processes and fostering innovation. Required Skills & Experience Bachelor's degree in computer science, Engineering, or related field. 5+ years of experience in software QA, with at least 3 years in a leadership role. Strong knowledge of testing techniques including: Black-box, White-box, and Gray-box testing Boundary value analysis, equivalence partitioning, exploratory testing Security testing tools (e.g., OWASP ZAP, Burp Suite) Accessibility standards (e.g., WCAG) and usability testing methods Performance testing tools (e.g., JMeter, LoadRunner) Experience with test automation frameworks (e.g., Selenium, Cypress, Appium). Familiarity with Agile/Scrum development environments. Hands-on experience with CI/CD tools (e.g., Jenkins, GitLab CI, Azure DevOps). Knowledge of DevSecOps practices and integration of security into QA processes. Excellent communication, leadership, and problem-solving skills. Bilingual (Spanish/English) preferred. Bilingual: English and Spanish US Citizen | US Resident Location: San Juan, PR EEO

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: Develops, implements, and maintains an organization's quality management system (QMS), ensuring compliance with standards and regulations through policies, audits, and corrective actions (CAPA). They lead cross-functional teams, manage document control, oversee vendor quality, and use data analysis to drive continuous improvement, ensuring products/services consistently meet customer and company quality goals. Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. * Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. * Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. * Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. * Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. * Co-ordinates legal requests in support of government investigations or litigations. * Ensures the quality assurance programs and policies are maintained and modified regularly. * Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. * Is accountable for overall program process, performance, and customer satisfaction. Shift: 40 hrs usually between 1 and 2 shift (8:30-5:30) Location: Juncos, PR Education: Engineering degree (prefertrable); Sciences Preferred Qualifications: * Hands on Experience on Projects/Scheduling for Medical Device manufacturing * Excellent Negotiating and Communication Skills * Risk Management/Critical Thinking * Conflict Resolution skills * Knowledge in Medical Devices regulations Skills: * Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets . Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management. * Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program. * Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. * Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. 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: Develops, implements, and maintains an organization's quality management system (QMS), ensuring compliance with standards and regulations through policies, audits, and corrective actions (CAPA). They lead cross-functional teams, manage document control, oversee vendor quality, and use data analysis to drive continuous improvement, ensuring products/services consistently meet customer and company quality goals. Responsibilities: Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Is accountable for overall program process, performance, and customer satisfaction. Shift: 40 hrs usually between 1 and 2 shift (8:30-5:30) Location: Juncos, PR Education: Engineering degree (prefertrable); Sciences Preferred Qualifications: Hands on Experience on Projects/Scheduling for Medical Device manufacturing Excellent Negotiating and Communication Skills Risk Management/Critical Thinking Conflict Resolution skills Knowledge in Medical Devices regulations Skills: Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets . Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management. Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program. Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. 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

Expect more. Connect more. Be more at Diebold Nixdorf. Our teams automate, digitize, and transform the way more than 75 million people around the globe bank and shop in this hyper-connected, consumer-centric world. Join us in connecting people to commerce in this vital, rewarding role. Ensures quality and consistency of customer service levels through continual review, feedback and service provider coaching, training and development. Listens in on calls, recordings and / or other customer interactions to evaluate service provider skills in dealing with customers. Verifies / ensures the accuracy and effectiveness of information or advice provided to customers. May act as 'floorwalker' to give immediate assistance to customer service associates regarding customer inquiries.

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

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence. Position Summary: The Quality 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: Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master Validation Plans for new processes or products. Review process validation protocols and reports; support other functional areas during validation activities. Collaborate with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans and other development procedures. Design and develop in-process and receiving quality systems for new processes and components. Define gages, tools, and equipment for developed test methods. Identify and control manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in root cause analysis and implementing corrective and preventive actions. Develop product quality plans, specifications, and risk analyses (including FMEAs) in conjunction with product development teams. Develop process monitoring systems by identifying critical process steps and applying methods to reduce variation and defects. Lead process improvement efforts by capturing quality metrics and performing analysis to enhance product design and development. Assist in creating quality tools and training materials to improve effectiveness. Evaluate adequacy and compliance of systems, operations, and practices against regulations and company documentation; may serve as auditor for development and manufacturing areas. Qualifications: Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field). 2-4 years of experience in an engineering role within a regulated industry (pharmaceutical, biotech, or medical device preferred). Excellent communication (Spanish/English) and teamwork abilities. This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

For Remediation services in the Quality Assurance area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry. Bilingual: Spanish and English Soft Skills: Attention to detail, organization, and writing skills Shift: Administrative, and according to the business Experience: Validation Master Plans Automation Systems Testing Process Development Manufacturing Process Engineering The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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 process validation protocols and reports. Support other functional areas during the validation activities. Collaborate 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. Define gages, tools and equipment for the test methods developed. Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support the implementation of complex & documenting release criteria. Develops product quality plans, documents, and systems by creating product specifications, quality specifications, and quality plans in conjunction with other product development team members. May be responsible for developing risk analyses and FMEAs. Develops Process Monitoring Systems by identifying critical process steps, applying methods to reduce process variation, and reducing/eliminating the cause of defects. Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. Assists in the creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as an auditor of areas of the client's quality system, such as development and manufacturing, as assigned. 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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the next piece?

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

The Quality Sr Engineer is responsible to provide quality support for manufacturing of products as per cGMP requirements and comply with the established quality management system. The Sr Quality Engineer manages and supervise the processes like incoming quality inspections, product quality controls, investigation of customer complaints, supplier quality audits, CAPAs, and maintain quality system as per ISO13485:2018 and 21CFR 820. The Sr Quality Engineer also communicate with the cross function teams to ensure the quality system compliance, provides training to the team of inspectors. Along with experience with ISO 13485 and 21CRF820, the Sr Quality Engineer also has experience with Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211). Position Authority: This position has the authority to ensure that the nonconforming products are not accepted for manufacturing and released for distribution. The Quality Sr Engineer supervises the processes that are assigned and delivers performances to meet the goal requirements. This position motivates, and provides training for the team of inspectors to ensure timely completion of activities and compliance with the quality system procedures. Essential Job Functions: The Sr Quality Engineer is required to perform the following activities related to processes such as CAPA, Incoming Quality Inspection, QMS, and Handling of NCR; Analyze product nonconformance and customer complaints. Maintain quality management systems compliance with the regulations such as 21CFR820 and ISO13485 requirements. Trend quality performance metrics and demonstrate continuous improvements. Lead CAPAs assigned for effective closure. Initiate, review and approve SCARs. Conduct assigned Internal Audits, publish audit reports, review and approve audit responses for nonconformance(s) Coordinate, plan, perform and report Supplier Audits. Assess material risk and develop incoming inspection plans. Support preparing and participate in audits including Customer, NB audits and FDA Inspections. Review validation strategies against quality system regulation and lead quality engineering teams for the execution of validation plans for assigned quality projects. Review validation protocols and reports Interact, communicate and timely respond to the customer for Customer issued SCARs, Audit Reports, Complaints, Change Notifications, etc. Support for preparing inputs to the management review meeting. Provide technical training and support to Quality Engineers of the site as well as to Engineering Assistants and Manufacturing Engineers. Be acknowledged as a subject matter expert (SME) in at least one quality subsystem (i.e. process/software validation, complaints, NC's, other) required to providing support to the Viant. Participate and lead communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other. Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced. Responsible for the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings. Knowledge and Education: Minimum of Bachelor's Degree in Technical Field (Engineering or Sciences) is required. Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired. Knowledgeable of processes such as Quality Management System, Documentation and Record Controls, CAPA, Change Management, Quality Audits, Product Quality Nonconformance, Supplier Quality Management, Process and Software Validation is required. Knowledge of Combination Devices and/or Pharmaceutical products and applicable regulations (CFR Part 210/211). Knowledge in root cause analysis tools Proficiency in the use of MS Project. Intermediate level of knowledge of Minitab statistical software. Bilingual English/Spanish - Advanced English level (written and spoken), technical writing and capable of leading presentations. Job Experience: Minimum 5 years of Quality Engineering experience in medical device manufacturing environment and/or pharmaceutical fields is required. Demonstrated use quality tools such as GR&R, pFMEA, Control Chart, Process Capability is desired. Experience in the following processes is required; Standard regulatory requirements such as cGMP, ISO13485:2016 and 21CFR820 CAPA process Participated in internal audits A part of team supporting for 2nd and 3rd party audits and inspections Process Validations i.e. IQ, OQ, PQ, & Software Validation Statistical Analytical tools such as Process Capability, GR&R, Control Charts Risk analysis such as pFMEA\\ Skills and Competencies: Well organized, able to multitask, prioritize and manage multiple deliverables while working in a fast -pace manufacturing environment. Exudes values of being customer-centric, accountable, collaborative, and respectful and demonstrates active listening. Self-motivated, with a strong desire to learn and improve self. Excellent attention to detail and accuracy. Establishes and maintains high standards for quality and considers excellence a fundamental priority. Excellent communication skills, with the ability to create reports and presentations to influence individual or group decision-making, and to provide training to various levels of employees. Ability to delegate tasks and projects appropriately according to an individual's strengths, aptitude and career direction. Ability to motivate a team to achieve goals. Excellent analytical, technical and troubleshooting skills. Hands-on approach to problem solving. Demonstrated understanding and application of modern manufacturing principles and methods to a medical device manufacturing operation. Demonstrated proficiency with Microsoft Outlook, Microsoft Project, and Microsoft Office applications. Highly self-motivated, focused, self-starter, willing to learn, and take up new responsibility and tasks. Ability to work independently and as a part of a team. Proficiency in at least one manufacturing technical field or any quality subsystem (i.e. process/software validation, CAPA system, statistical techniques, risk management, other.) acquired through either formal training and/or work experience. Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes. Decision making: Capable of making higher risk decisions within specific value streams.

Responsible for assessing the processes quality 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 client to designs and installs quality control process sampling systems, procedures and statistical techniques. Designs and specifies inspection and testing mechanisms and equipment. Analyzes client's production limitations and standards. Recommends revision of specifications when indicated. Formulates or assists in formulating quality control policies and procedures. Develops economics of any quality control program when required. Execute and\/or approve process validation activities (test method validations, characterizations, IQ, OQ, and PQs) and process risk assessments. Requirements BS Degree in Engineering or Applied Sciences. One to five years of work experience in a similar role. Strong customer service skills are necessary. Fully bilingual "}}],"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":"Farmacéutico"},{"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":"Quality Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054462","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjlUq@IeRCLplIHBBV22Is18\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}

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.

Permanent About Heraeus Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead. About Heraeus Medevio Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds. To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today. Position Summary The Continuous Improvement Engineer II will play a crucial role in developing and implementing global operational excellence standards and continuous improvement activities across various operational and business areas. The position involves supporting the embedding of HPS Operational Excellence principles into product and process development, training and mentoring teams, and identifying operational improvement opportunities using lean principles and 6-sigma methodology. The Continuous Improvement Engineer II also oversees IT Systems activities through coordination of HSY and is the site ERP SuperUser. What You'll Do Everyday: * Demonstrating leadership in conveying operational excellence principles and developing global operational excellence standards. * Implementing continuous improvement activities for various operational or business areas. * Supporting the embedding of HPS Operational Excellence principles into product and process development activities and ongoing operations. * Participating in the definition of HPS Global Operational Excellence standards as a member of the CI Team. * Rolling out HPS Operational Excellence standards in coordination with operational leaders. * Training, mentoring, and coaching engineering and operations teams on HPS Operational Excellence principles and methods. * Identifying, evaluating, supporting prioritization, and implementing operational improvement opportunities using lean principles and/or 6-sigma methodology. * Conducting cost/benefit analysis for changes to processes and/or equipment. * Supporting the optimization of process flows, line layouts, staffing, and workstation design to improve product scalability. * Leading value stream mapping exercises to identify waste and areas for improvement. * Other duties as assigned. What We're Looking For: * Bachelor's degree in Engineering, Industrial Engineering preferred. * Minimum 4 years of experience in medical sevice or component manufacturing, as Black Belt certified preferred. * Knowledge of medical device regulations, statistical analysis, design and manufacturing. * Basic understanding of manufacturing equipment and computer programming. * Proficiency in reading, writing and speaking English with the ability to interface and influence at all organization levels. * Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations. * Proficient in the use of project management tools, data analytic, statistical tools, and application of continuous improvement methodologies such Lean, Six Sigma or equivalent. * Ability to train, lead, mentor, coach and inspire teams to significantly impact the business. * Demonstrated proficiency in strategic thinking, change management, facilitation, and interpersonal effectiveness. * Proven leadership skills and business acumen; performance driven. * Works with positive attitude and acts within the principle of Heraeus Core Values and Code of Conduct as applicable for position. Curious? Apply now! We are interested in finding the best candidates, and they may come from a nontraditional background. So please don't hesitate to apply, even if you aren't an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio! Any further questions? Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [[cust_RecTeam]]. Or visit us at jobs.heraeus.com. ReqID: 57820

Our client, a leader in manufacturing components for electrical devices such as switches (breakers) and control systems, uses molding and metal stamping processes for customers in the appliance and electronics sectors. They specialize in the production of high-precision parts for assembly and work with advanced technology. They are seeking a Process Engineer (Injection Molding). Job Summary: We are seeking a highly skilled and experienced Process Engineer with a strong background in the sector, optimizes, and troubleshoots injection molding processes for high-quality, efficient production, focusing on scientific molding, process validation, data analysis, tooling integration, and leading continuous improvement activities using Lean methodologies (SMED, TPM) , while also mentoring and coordinating tool-shop and maintenance operators. The person will be also involved in the preparation of new products launches and cost analysis . Key Responsibilities Process Development & Optimization: Establish and refine molding parameters, develop new processes for new products, and implement changes for better quality, cycle time, and efficiency. Troubleshooting: Diagnose and resolve complex material, tooling, equipment, and process issues. Validation & Documentation: Perform validations, conduct process capability studies, and maintain accurate process documentation (process sheets, work instructions). Tooling & Equipment: Supervise and mentor toolmakers, maintenance mechanics, and other technical personnel. Provide hands-on leadership in troubleshooting, repairing, and maintaining tools and equipment in good conditions. Ensure that team members are working efficiently and safely. Monitor and analyze Key Performance Indicators (KPIs) and Overall Equipment Efficiency (OEE) to identify performance gaps and implement corrective actions. Work closely with operations teams to meet or exceed production goals and quality standards. Assist in the preparation and production of various plastic components and systems, ensuring that processes run smoothly and meet customer specifications. Provide support during equipment setups, process validations, and production runs. Work closely with cross-functional teams (including quality, planning, production, maintenence) to ensure that products are manufactured to specifications. Participate in team meetings and provide technical input for product improvements or process changes. Leadership & Training: Provide technical leadership, mentor technicians and operators, and train personnel on new processes and best practices. Qualifications: Education: Degree in Mechanical/Industrial Engineering or related field. Experience: Several years of experience and a solid background in injection molding, tool design and maintaining, process development, and new product introduction (NPI) Technical Skills: Proficient in scientific molding principles, data analysis, Moldflow (optional but beneficial), robotics (optional), and validation protocols. Methodologies: Knowledge of Lean Manufacturing (SMED, OEE, TPM) , Root Cause Analysis (8D, CAPA, Pareto). Soft Skills: Strong problem-solving, leadership, communication, attention to detail, and ability to work in a fast-paced environment with a sense of urgency and proactivity. Availability to occasionally travel for customer visits outside Puerto Rico and/or for technical support and site visits, in case of need

EQVAL Group, Inc . is a company that provides technical and engineering services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies) and other service companies. We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service. The Process Validation Engineer will support operations in a Medical Devices manufacturing environment and is expected to perform the following activities and demonstrate the following qualifications: Minimum Requirements: Bachelor's degree in Engineering. At least one (1) year of experience in Medical Device process and GMP-regulated environments (co-ops and internships are considered as experience). Experience in the design and execution of validation protocols and documentation, including URS, DS, IQ, OQ, and PQ, as well as deviation handling and report generation. Knowledge of statistical analysis (e.g., GR&R) and data management, including the use of statistical tools such as Minitab. GAP 3.0 or higher preferred. Fully bilingual in English and Spanish. Please note that this position and requires 100% on-site presence in Dorado, Puerto Rico.

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: Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. 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. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Qualifications: Bachelor's degree in engineering (Mechanical, Electrical or Chemical preferred) 4+ years of relevant experience Experience with Risk management documentation: pFMEAs Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Basic knowledge in statistics (preferably using Minitab) Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing) Experience investigating manufacturing operations events in support to product disposition Experience assessing and tracing manufacturing defects/rejects trends Knowledge in Medical Devices regulations Experience working and executing Design transfer activities Experience with projects to implement new products: design requirements validation, manufacturing controls (not Operational Excellence) Experience reviewing and approving validation test plans, reports, and deviations Capable of performing statistical analysis to support validations and product release Available for 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.

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***

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!

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