Quality engineer jobs in Caguas, PR

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and\/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigation. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Other duties may be assigned. Requirements Minimum 4 years of relevant experience within the regulated industry. Experience in Investigation and root cause analysis. Knowledge in Process Validation, Computer System Validation and Technical Writing. Bilingual. Bachelor Degree in Engineering or Science Completed. Willing to work 100% on site and weekend or overtime when needed. "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Sr Quality Systems Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015976001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26gCial6RtckyxSOPdzrQGXM\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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: Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or 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. Coaches and reviews the work of lower level specialists Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Qualifications: Bachelor's degree in related area 4 years of relevant experience with Quality systems Investigation and root cause analysis skills Technical writing knowledge. Organization and Communication skills Process Validation and Computer software validation knowledge Availability 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.

For Engineer services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Sciences and over eight (8) years of exposure within the Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Excellent Communication skills, and Positive attitude. Shift: 1st Shift Experience in: Quality Systems, including CAPA, Change Control, and Validations Medical Device Regulatory Requirements and compliance standards Quality and Regulatory Audit activities, including preparation, execution, and follow-up The Personality Part: Our Next Piece is someone who leads with empathy, communicates with clarity, and thrives in complex, collaborative environments. They coach others, solve problems creatively, and make a meaningful impact through trust and initiative. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Work directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet guidelines. Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages. Coordinate legal requests in support of government investigations or litigations. Ensure the quality assurance programs and policies are maintained and modified regularly. Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

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

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.

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

Designs and plans layout for such activities as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to Engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure compliance with company programs procedures and applicable quality system regulations and standards.

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

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

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: We are seeking a Process Engineer with strong experience in validations, including Master Validation Plans, IQ, OQ, MSA, PQ, and related activities. The candidate must be fully bilingual and have at least two years of experience in validation within a medical device company. Validation lifecycle knowledge / Hands on experience (Writing and executing IQ/OQ/PQ protocols among others) Troubleshooting equipment / process failures Analyzing test data and statistical trends Qualifications Requirements/Knowledge/Education/Skills: BBA in Enigneering At least two years of hands-on experience in validations within the medical device industry. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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

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

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Shift: 1st Shift Location: Villalba, PR Education: BS Engineering Preferred Qualifications: Change control of Medical Devices Equipment Commissioning / Qualification Process Validation Computer System Validation (CSV) Manufacturing, Packaging and Laboratory Equipment Technical experience (Trouble shooting) or any similar experience or background Quality / Process Control / Assurance of Medical Devices Skills: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

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

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * Process Engineer * Experience in Process Engineering for the Medical Device Industry * Experience in Qualifications Qualifications: * Bachelor's Degree in Science or Engineering. * Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Must be fully bilingual (English / Spanish) with excellent oral skills. * Must be proficient using MS Windows and Microsoft Office applications. * Strong knowledge in regulatory guidance * Experience with Process Engineering and the development and execution of Validation Protocols * Technical Writing skills and investigations processes. * Available to work extended hours, possibility of weekends and holidays.

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":true,"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"}

Develop Validations Documents (Master Validation Plans/Reports, Test Method Validations, IQ, OQ and/or PQ, CSV related documents), Execute Validations in assigned Manufacturing Areas, and generate Reports. Document and execute IQ for label printing, Implement Manufacturing processes changes through CCB. Able to implement EU MDR requirements (such as PIC card implementation, Manufacturing/PFMEA, FAI, manuals and new pins implementation / FW Configuration changes and other required activity per EU MDR requirements). Develop and/or revise PPM or DOTM as required. Support during submission documents review as applicable. Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. 1. Some experience in process validation , test method validation, CSV, handling of manufacturing process changes implementation (at packaging and/or manufacturing process flow). 2. Responsible, able to learn fast and adapts to continues changes in project schedule priorities as required. Able to coordinate and manage activities with multiple functions, able to apply problem solving techniques (critical thinking skills) to move roadblock without impact project schedule activities 3. Teamwork oriented, good communication skills, results oriented Education Required: Bachelor degree in engineering Years' Experience Required: Minimum of two years preferred with some experience, intermediate position. Willing to evaluate good potential candidates at entry level

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Validation Engineer - Process Development. Requirements: * BS Engineering with at least 3 years of medical devices or pharma experience. * Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. * Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. * Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. * Design and develop in-process and receiving quality systems for new processes and components. * Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. * Define gages, tools and equipment for the test methods developed. * Generate manufacturing instructions for new processes being developed. * Work cross-functionally with other departments to accomplish PD tasks.

Responsibilities may include the following and other duties may be assigned: Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Define and implement appropriate measures to ensure product quality. Review software systems design, change specifications, and project plans against contractual and regulatory requirements. Ensure compliance with applicable specifications, tools, techniques, and methodologies. Provide or direct verification and validation of software system requirements, traceability, and testability. Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations. Represent the organization as primary contact for projects/initiatives, communicating with internal and external stakeholders. Provide mentorship, coaching, and training to other professionals within the team. Experience Requirements: Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro/chemistry experience). Advanced degree accepted with minimum 5 years of relevant experience. Automation / Controls / Programming hands-on experience CAPA, investigations, root cause analysis, and technical writing Computer software validations and GAMP knowledge - hands-on experience (Additional) Strong knowledge in medical devices regulations Experience with risk management documentation (PFMEAs) Experience designing validation strategies (e.g., requirements flow down from design to manufacturing) Perform and/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes) Knowledge of medical device regulations and GAMP standards Education Requirement: Bachelor's degree in Engineering (Mechanical, Electrical, or Computer/Software preferred). Technical Skills (Must Have) Investigation and root cause analysis skills Technical writing knowledge Strong organizational and communication skills Process validation and computer software validation knowledge Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports Experience in medical devices manufacturing Interpersonal skills to support product disposition investigations (PFMEA, atypical events) Automated source code management Computer software programming (including embedded software programming) Development of control plans and PFMEA Additional Technical Areas (Hands-On/Knowledge Required) Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting Vision Systems Instrumentation: overview and application Control Systems Data Structure & Sources Data Analysis Tools: SQL, Python, R Data Management Databases: data extraction, transformation, loading, database creation/maintenance, query overview (SQL/Non-SQL) Programming: Assembly (C), Object-Oriented Programming (Python, Java), error handling, abstract data types GUI/HMI Design: FactoryTalk, RSView Communication Networks Operating Systems FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022) Nice to Have Additional investigation and root cause analysis expertise Work Methodology: Full time contract 100% on-site job in Medtronic- Juncos, PR First contract until August 2026 based to performance and budget availability. Willing to work 1st or 2nd shift