Quality engineer jobs in Vega Alta, PR - 231 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.

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.

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

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?

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"}

The Quality Engineer will support the development, review, and maintenance of quality systems and documentation in a regulated manufacturing environment. This role focuses on validation oversight, document evaluation, and continuous improvement of inspection and assembly processes. Responsibilities: Execute and support Test Method Validation and Cleaning Validation activities. Update and create inspection methods for products / components. Review / update instructions for manufacturing control inspections and other related documentation. Review validation documents such as IQ, OQ, PQ. Review and manage investigations. Collaborate with cross-functional teams to ensure compliance with internal and external quality standards. Support CAPA investigations, root cause analysis, and corrective actions. Participate in audits and regulatory inspections as needed. Other functions that may be assigned. Qualifications: Bachelor's degree in Engineering or related field. Minimum of 5 years of experience in Quality Assurance or Engineering within a regulated industry (medical device preferred). Knowledge of validation protocols. Strong analytical, documentation, and communication skills. Fluent in English and Spanish preferred. Work Methodology: 100% On-site & 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

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"}

Our Supplier Quality Engineer (SQE) for Non-Destructive Evaluation (NDE) & Testing Processes, will apply their demonstrated knowledge of NDE to lead improvement and sustain quality practices within our Composites supply chain. SQE Deliverables Include: - Support supplier process quality strategy for GE Aerospace. - Drive quality for assigned suppliers, including quality plan implementation. - Lead suppliers through root cause and corrective actions to address any quality findings. - Select suppliers through qualification processes. - Own supplier quality system requirements, drive improvements utilizing supplier scorecards. - Own supplier audits, ensuring compliance, and driving improvement plans where needed. - Mentor team members within the Composites supplier quality team. - Demonstrate an in-depth understanding of key business drivers; uses this understanding to accomplish own work. - Demonstrate an in-depth understanding of how work within our own team integrates with other teams and contributes to the area. **Job Description** **Roles and Responsibilities** + Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs. + Position includes regular supplier audits, in conjunction with our GE Aerospace process experts and system assessments for quality preparedness and process controls to remain adherent to GE Aerospace process specifications and agency regulations. + Requires specialized knowledge within the field of NDE, including but not limited to: CT Scanning & Ultrasonic evaluation processes. Influence the development of strategy for the area of responsibility, including control of resources and influences policy formulation. + Interprets simple internal and external business challenges and recommends best practices to improve products, processes, or services. Stays informed of industry trends that may inform work. Coordinating with the GE Aerospace Inspection Solutions (AIS) experts and operations teams and their approved supplier technical plans, to ensure product meets the approved process requirements and specifications. + Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. + May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view. **Required Qualifications** + Bachelor's Degree from an accredited college or university (or a high school diploma/GED with a minimum of 4 years (Materials Science, Physics, Chemistry, Mathematics, or Engineering) experience + minimum of 3 years (Materials Science, Engineering, or Quality) related roles experience **Desired Characteristics** + demonstrating proficiency of their time within Non-Destructive Evaluation operations, team leadership, and aerospace supply chain familiarity. + Demonstrated expertise and experience with Non-Destructive Evaluation and Testing + Proficiency in reading and applying engineering drawings and specifications. + Demonstrated organizational leadership in quality systems foundations and adherence, via industry requirements and audit experience. + Demonstrated experience in manufacturing or supplier quality, statistical analysis + Certified or willingness to achieve a Level 2 NAS410 qualification for certification in CT, and UT + Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis and quality experience + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker The base pay range for this position is 110-130k. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on [include anticipated date expected to close December 1. 2025. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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.

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: 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.

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 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 the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies and maintains quality standards. * Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. * Performs statistical analysis. * Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends) Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Chemical preferred (not Science) Preferred Qualifications: * Experience with Risk management documentation: pFMEAs * Basic knowledge in statistics (preferably using Minitab) * Basic knowledge in designing 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 * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) * CAPA/ Investigations/ Root Cause Analyses/Technical Writing * Risk Management (pfmea)/Critical Thinking Skills: * Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . * Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. * Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. * Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. * Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. * Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. 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 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 the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends) Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Chemical preferred (not Science) Preferred Qualifications: Experience with Risk management documentation: pFMEAs Basic knowledge in statistics (preferably using Minitab) Basic knowledge in designing 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 Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Knowledge in Medical Devices regulations Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) CAPA/ Investigations/ Root Cause Analyses/Technical Writing Risk Management (pfmea)/Critical Thinking Skills: Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. 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

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

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***

ECHO Consulting Group is a highly successful and growing consulting company for the Healthcare industry for the last 12 years. ECHO offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in a work environment that values trust, respect, teamwork, creative talent, enthusiasm and diligence. Job Description Able to integrate into a dynamic cross-functional team responsible for supporting/implementing activities. Develop and execute protocols and prepare final reports following plant procedures and regulatory requirements. Analyze data, and present conclusions and recommendations to clients. Organize, schedule and track projects in order to meet client requirements within agreed time lines. Qualifications A minimum Bachelor's degree in a related science (Engineering, Chemistry, Biotechnology or Life Science) Experience working in a FDA Regulated environment. A thorough knowledge of Good Documentation Practices (cGDP), excellent verbal and written communication skills. Experience in writing technical documents, including validation documents (protocols and reports), assessments and investigations. Excellent interpersonal skills, coupled with a superb attention to detail, excellent review and analytical skills. Must have strong ability to organize and manage multiple tasks in a fast-paced environment. The ability to work effectively with team members and work under minimal supervision. Filed experience in validation equipments. Additional Information Interested send your resume to [email protected]

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!

About Zenus Zenus' mission is to facilitate banking beyond borders. Operating in over 150 countries, we enable people and businesses to open a US bank account online, without the need to be a US citizen, resident, or a company registered in the US - opening up the security, stability and freedom of US banking to the world. As a signatory of the UN's Principles for Responsible Banking, we are committed to making finance fair. Our state-of-the-art technology, exclusive partnerships and proprietary processes are now being made available via our embedded banking services to enable other businesses to create new financial service experiences for their customers. Headquartered in San Juan, Puerto Rico we have a diverse and inclusive team. This position is hybrid, requiring on-site presence with a schedule of: 3 days on-site 2 days remote About the role The Security Site Reliability Engineer (SSRE) is responsible for ensuring the reliability, consistency, and continuous execution of security controls across CI/CD pipelines and cloud delivery workflows. Operating within the SecOps domain and reporting to the Information Security Officer (ISO), the SSRE focuses on automating security controls, enforcing policy-as-code, and guaranteeing that security validations always execute as designed throughout the delivery lifecycle. This role owns how security controls are executed and enforced, not application security testing, cloud configuration ownership, or service uptime. Responsibilities & duties: Integrate and maintain automated security controls within CI/CD pipelines (SAST, SCA, DAST, IaC scans). Enforce security gates and policy-as-code validations across all delivery stages. Ensure the reliability and consistency of security checks (controls never skipped or bypassed). Monitor execution health of security controls and detect failures or misconfigurations. Maintain dashboards and metrics related to security control execution (not service availability). Collaborate with AppSec to ensure application security scans are executed correctly. Collaborate with CloudSec to ensure cloud security policies are enforced during deployments. Support security incident investigations related to control failures or pipeline bypasses, under ISO guidance. Maintain automated security evidence (logs, reports, pipeline artifacts) for audit purposes (minimum 24 months). Develop and maintain SSRE runbooks, control definitions, and operational workflows. What you need for this role: 3+ years of experience in DevSecOps, security engineering, or CI/CD automation roles. Strong hands-on experience with CI/CD platforms (Azure DevOps, GitHub Actions, Jenkins). Experience integrating security scanning tools into pipelines. Knowledge of Infrastructure as Code (Terraform, Bicep, ARM) from a validation perspective. Experience with scripting and automation (Python, PowerShell, Bash). Understanding of cloud-native security concepts and delivery pipelines. Familiarity with compliance-driven environments (ISO 27001, SOC 2).