Process engineer jobs in Guaynabo, PR

Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and\/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. ***Other duties may be assigned.*** Requirements Minimum 4 years of experience in the regulated industry, preferably in Medical Devices. Experience in Change control of Medical Devices, Equipment Commissioning \/ Qualification, Process Validation, CSV, Manufacturing, Packaging and Laboratory Equipment. Technical (Troubleshooting), Quality, Process Control and Assurance. Bilingual. Bachelor Degree in Engineering completed. Willing to work 100% on\-site in Juncos, PR. Top 3 things you are looking for in a candidates experience: Proficient in validation process, CSV, PV Proficient in Troubleshooting, Equipment Setups Proficient in document management "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Engineering"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016933001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26sJb6@sa8AAn7A.ZodxIbkI\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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 technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Qualifications: Bachelor's degree in Engineering 4 years of relevant experience Proficient in validation process, CSV, PV Proficient in Troubleshooting, Equipment Setups Proficient in document management Change control of Medical Devices Equipment Commissioning / Qualification Process Validation 4. 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 Device 1st shift (8am to 5pm) 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.

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.

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.

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

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.

In a full automation role the Sr. Associate Mfg Systems will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards. Functions: - Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards. - Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team. - Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues. - Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies. - Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications. - Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance. - Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs. - Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems. **Other functions that may be assigned Requisitos Trabajo presencial en Juncos; Puerto Rico Los candidatos deben tener conocimiento en PLC (el proceso de conectarse a PLC), conocer a profundidad sobre Troubleshooting (cómo identificar la señal que está llegando), sistemas de inspección, el funcionamiento del sistema de Visión y resolver problemas técnicos. Un "plus" en evaluaciones: conocimiento en escala, sistemas de inspección, sistemas de mantenimiento (ej. Maximo), disponibilidad completa, habilidad de trabajar en equipo y trabajar con mínima supervisión. Requiere que la persona domine idiomas inglés y español - oral y escrito. Education: Master's degree or Bachelor's degree and 2 years of Engineering experience or Associate's degree and 6 years of Engineering experience or High school diploma / GED and 8 years of Engineering experience. Preferred Qualifications: Automation Background in programming, installation of manufacturing process controls, automation and field instrumentation technologies. Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs. Working knowledge of pharmaceutical/biotech processes. Familiarity with validation processes and documentation in a highly regulated environment. Strong verbal communication skills in English and Spanish. Skills in the following areas: Problem solving and root cause analysis. Basic technical report writing. Basic technical presentations. Personal Organization. Dealing with and managing change. Technical (Equipment Specific). Analytical Problem Solving. Computer Literacy Knowledgeable on Rockwell Automation Factory Talk & ControlLogix PLC Platform. Knowledgeable on Rockwell SLC500 PLC families Controllers. Knowledgeable on Rockwell Automation FTView SE and FTBatch systems. Knowledgeable on DeviceNet technologies. Work schedule flexibility to support 24/7 operations. Knowledge in programming language (e.g. VBA, SQL). Knowledge in vision system technology. Knowledge in serialization process. Basic Knowledge in robot or cobot programming. Skills: - Leadership and teambuilding - Verbal communication - Written Communication/Technical Writing - Organization - Facilitation - Dealing with and managing change - Comprehensive understanding of validation protocol requirements - Technical (Equipment Specific) - Analytical Problem Solving - Project Management & Planning - Scheduling - Computer Literacy Work Methodology: 100% on-site job Full time opportunity Shift: 5:00 am to 5:30 pm or 5:00pm to 5:00am; including alternate weekend Professional services or Temporary contract Beneficios Rango de salario disponible $35-40 por hora - servicios profesionales. Detalles Nivel mínimo de educación: Universitario (Graduado)

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)

For Engineering and Project Management services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Engineering (Preferred Mechanical, Electrical & Computer) & five (5) years of relevant experience within the Medical Devices or Pharmaceutical industry. Skills: Attention to details and verbal and written communication skills, Bilingual (Spanish & English). Shift: 1st and according to business needs. Experience in: Manufacturing line process and production. working with a revision control system, preferable Git & Gitlab MES Proficiency in R/SQL/BASH programming and Linux Integrate new and/or existing equipment/automation. The Personality Part: Our Next Piece treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards, improve production efficiencies, and manufacturing. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling/fixture and equipment installation, and assessment of inputs. Develops manufacturing processes that apply to statistical process control and may develop those techniques, including the measurement systems. Ensures processes and procedures comply with regulations. We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

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

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

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

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

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Established and productive individual contributor that works independently with general supervision on larger, moderately complex projects / assignments. Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones and may have some involvement in cross functional assignments. Communicates primarily and frequently with internal contacts and with the external interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area Responsibilities: Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Shift: 1st Shift Location: Villalba, PR Education: Mechanical, Chemical, Electrical Engineering Preferred Qualifications: Collaboration and Teamwork with adaptability project tasks requirements. Communication skills (English / Spanish) Problem-Solving Skill and Continuous Improvement Mindset Attention to details Skills: Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

**What Commercial Technologies Software Engineering contributes to Cardinal Health** Commercial Technologies manages the enterprise's portfolio of commercial technologies to maximize the business value of the technologies and enhance the customer experience. This function creates strategies for the portfolio and innovative solutions based on relationships with business leaders, develops back-end solutions and capabilities, and improves the front-end experience. Commercial Technologies Software Engineering develops design options, process improvements and back-end solutions for commercial technologies to maximize performance and suitability for business needs. This job family manages engineering projects and plans for commercial technologies and interfaces with product managers to develop objectives. This job family assesses product systems, identifies opportunities for process and system improvements, and develops solutions through application of engineering principles. **Responsibilities** + Responsible for designing, developing, implementing, and supporting applications, systems and IT products required to achieve business objectives. + Plans and executes system implementations that ensure success and minimize risk of system outages or other negative production impacts. + Demonstrates problem solving ability that allows for effective and timely resolution of system issues including but not limited to production outages. + Analyze production system operations using tools such as monitoring, capacity analysis and outage root cause analysis to identify and drive change to ensure continuous improvement in system stability and performance. + Provide technical guidance to managed service partners. + Participate in code and design planning/reviews to ensure industry standards and best practices are being met + Establish and develop relations with business stakeholders + Design & customize technological systems and platforms to improve customer experience + Ensure aligned objectives and execution across internal and external stakeholders to create mutually beneficial partnerships to identify areas of growth and innovation + Advise on short and long term technology and growth planning + Ensure product and services are compliant with company's policies + Manage strategic partnerships with preferred technology vendors + Recommends new practices, processes, metrics, or models + Must be able to define tasks, milestones, and deliverables that meet stated project objectives + Independently determines method for completion of new projects + Serve as an escalation point for complex functional and technical issues + Provide end-to-end views on how all components fit together + "Connecting dots" across various business and technology areas **Qualifications** + 4-8 years of experience, preferred + Bachelor's degree in related field, or equivalent work experience, preferred + Experience in T-SQL, Windows Servers, .Net, Azure Logic Apps & pipelines, Swaggerhub, APIGEE, Splunk, Postman, Azure devops + Experience with GuardianRX, Cperx, Queen City, CMS Wordlink, Omnisys, and Genesis a PLUS + Experience in designing, building, deploying, managing, and enhancing applications within the Software Development Life Cycle (SDLC) processes including requirement analysis and system design, and/or software engineering principles + Experience with CI/CD pipelines such as Azure Dev Ops, GIT + Working experience translating business objectives into Strategic technology plans + Strong leadership skills, including the ability to effectively partner with business leadership and key business stakeholders. + Strategic mindset and ability to lead with business objectives + Strong understanding of infrastructure platforms such as operating systems, databases, application servers, cloud. + Strong understanding of industry trends and relevant emerging technologies + Strong problem solving and analytical skills, and the ability to communicate technical information to both technical and non-technical users across various domains. + Perspective on industry-wide best-practices + Experience in Healthcare industry a plus + Experience in data analytics and/or data science a plus + Enterprise or Solution Architecture experience a plus **What is expected of you and others at this level** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **Anticipated salary range:** $93,500 - $140,280 **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:** 10/30/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

The Quality Engineer II will be responsible for supporting validation, risk management, and quality assurance activities in a regulated medical device manufacturing environment. This role requires expertise in validation protocols, statistical analysis, and regulatory compliance, with the ability to work cross-functionally with engineering, manufacturing, and quality teams to ensure product and process excellence. Key Responsibilities Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production. Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained. Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV. Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release. Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance. Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA). Lead complaint-handling activities in collaboration with operating unit members. Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations. Perform system administration and configuration of quality information technology systems. Prepare and maintain standard operating procedures (SOPs) for quality systems. Verify and document the effectiveness of CAPA and non-conformance resolutions. Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives. Report on validation activities to fulfill regulatory requirements. Minimum Requirements Bachelor's degree in Engineering (completed) + minimum 3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing). or Master´s degree in Engineering + 1-2 years of direct related experience. Experience with risk management documentation (pFMEAs). Experience in process validation and equipment qualification (excluding cleaning processes). Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory). Basic to intermediate statistical analysis skills, preferably with Minitab. Knowledge of defining validation strategies from design to manufacturing. Knowledge of Good Manufacturing Practices (GMP) and medical device regulations. Bilingual (English & Spanish - oral and written). Willingness to work 100% on-site. Preferred Qualifications (Nice to Have) Experience with design transfer activities and new product introduction projects. Experience investigating manufacturing events and supporting product disposition. Lean Six Sigma Green Belt Certification. Experience in defect/reject trend analysis. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project). Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR - ABRA Suite, Gallup Online Tool. Strong problem-solving and collaboration skills. Availability to work overtime and weekends when necessary. Work Methodology: Full time contract 100% on-site job in Medtronic-Villalba, PR 6 months of first contract with potential extensions based on performance and budget availability Administrative shift with availability to work non administrative hours or weekends

At INVID, we're looking for a highly skilled and motivated Azure Application Engineer to lead the automation, scalability, and reliability of our cloud infrastructure within the Microsoft Azure ecosystem. This role is essential in bridging development and operations, ensuring seamless CI/CD pipelines, secure deployments, and a resilient cloud architecture. The ideal candidate is passionate about Infrastructure as Code, cloud-native technologies, and driving continuous improvement. You'll collaborate closely with our development, QA, and security teams to implement best practices in DevOps and cloud security, while optimizing performance, cost-efficiency, and system resilience. Requirements: Analyze application architecture and dependencies to determine cloud readiness and define migration strategies (Rehost, Refactor, Replatform). Collaborate with architects to ensure application design aligns with Azure cloud best practices. Assist in migrating applications to Azure using tools like Azure Migrate, Database Migration Service (DMS), and Azure App Service Migration Assistant. Configure and deploy applications on Azure infrastructure, ensuring minimal downtime. Validate application functionality, data consistency, and system performance after migration. Troubleshoot and resolve application issues to ensure seamless operation in the Azure environment. Configure applications to leverage Azure services such as Azure App Service, Azure SQL, Azure Functions, and Cosmos DB. Implement monitoring and logging solutions using Azure Monitor, Log Analytics, and Application Insights. Collaborate with DevOps teams to integrate applications into CI/CD pipelines using Azure DevOps or GitHub Actions. Develop scripts and automation workflows for repeatable application setup and configuration. Work closely with migration architects, cloud engineers, and QA teams to ensure successful migrations. Actively participate in Scrum ceremonies, including sprint planning, daily stand-ups, and retrospectives. Maintain comprehensive documentation for application configurations, migration processes, and test results. Share insights and knowledge with team members to enhance overall migration efficiency. Requirements: Minimum of 3+ year experience in a security engineering role, with experience in network security, application security, and security frameworks. Bachelor's degree in related area and / or equivalent experience / training. Proficient in Azure services such as Virtual Machines, Azure App Service, Azure SQL Database, Storage Accounts, and Networking (VNets, NSGs). Experience with Azure migration tools like Azure Migrate, DMS, and App Service Migration Assistant. Strong experience in deploying, configuring, and maintaining applications in Azure environments. Familiarity with modern application architectures, including microservices and serverless computing. Proficiency in scripting languages such as PowerShell, Python, or Bash. Experience with Infrastructure as Code (IaC) tools like ARM templates, Bicep, or Terraform. Hands-on experience with Azure Monitor, Application Insights, and Log Analytics for application monitoring. Strong problem-solving skills for diagnosing application and system issues. Experience working in agile environments, participating in Scrum practices, and contributing to iterative delivery. Excellent analytical and troubleshooting skills. Strong communication and collaboration abilities. Detail-oriented with a focus on delivering high-quality outcomes. Strong analytical and troubleshooting abilities. Excellent communication and teamwork skills. Ability to manage multiple priorities in a fast-paced environment. Excellent computer proficiency including JIRA Nice to have skills: · Experience with advanced Azure services like AKS (Azure Kubernetes Service), Azure Logic Apps, and Azure Synapse Analytics. · Understanding of Azure Identity and Access Management (IAM) and security best practices. · Familiarity with Azure Cache for Redis and Content Delivery Networks (CDNs) for performance optimization. · Knowledge of scaling and tuning applications on Azure for cost-efficiency and performance. · Experience with CI/CD pipelines in Azure DevOps or GitHub Actions. · Knowledge of containerization and orchestration tools such as Docker and Kubernetes. · Proficiency in validating application functionality, data consistency, and workload dependencies during migrations. · Microsoft Certified: Azure Developer Associate or Azure Solutions Architect Expert. · Ability to mentor and guide junior engineers. · Proactive and adaptable in dynamic project environments Other Requirements: Must be bilingual (English and Spanish) Must be a US Citizen | US Resident Location: HYBRID in San Juan, Puerto Rico EEO

Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Asset Reliability Engineer (Automatic Visual Inspection) What you will do Let's do this. Let's change the world. In this vital role you will lead Maintenance Excellence and Continuous Improvement to drive equipment, system, and process reliability across Automatic Visual Inspection operations. This role ensures that assets perform consistently and predictably while meeting Amgen's high standards for safety, quality, and compliance. The engineer partners closely with Operations, Maintenance, Quality, Engineering, PD and Digital Technology to reduce unplanned downtime, improve system robustness, strengthen data integrity, and enhance lifecycle performance-using disciplined reliability practices, standard work, and a culture of continuous improvement. Specific responsibilities include but are not limited to: Act as the reliability subject matter expert (SME) for assigned equipment and process areas. Own the Reliability Improvement Project Portfolio prioritizing initiatives, aligning stakeholders, and driving execution to measurable outcomes. Lead formal root cause analysis (RCA) investigations using established methodologies. Conduct Reliability Centered Maintenance (RCM) analyses and develop risk-based asset care strategies. Optimize preventive and predictive maintenance programs within EAM/CMMS for compliance and efficiency. Implement and sustain condition-based monitoring technologies (e.g., vibration, thermography, ultrasound, oil analysis, IIoT). Monitor and analyze asset performance data; develop reliability KPIs and insights (e.g., MTBF, MTTR, failure trends). Provide reliability input for capital projects, design reviews, commissioning, and qualification activities. Support technology transfers, system upgrades, and network initiatives to enhance reliability. Collaborate with Operations, Maintenance, Quality, and Engineering to resolve recurring issues and drive improvements. Mentor junior engineers and technicians. Communicate reliability risks, mitigation plans, and progress to site leadership. Promote a reliability-centered culture, anchored in safety, quality, and operational discipline. Analyze performance data, identify trends, and apply root cause analysis to drive improvements. Build relationships across functions and OEM's. Share knowledge to support team and network success. Model a culture of accountability, safety, and continuous learning in alignment with Amgen values. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual contributor with these qualifications. Basic Qualifications: Master's degree in Engineering Or Bachelor's degree in Engineering and 2 years of Engineering Support experience Preferred Qualifications: ·Proficiency with CMMS/EAM systems and reliability analytics tools. ·Ability to interpret complex data sets and drive cross-functional actions. Experience in biotech or pharmaceutical manufacturing. Strong understanding of cGMP, validation principles, and equipment qualification lifecycle. Demonstrated expertise in RCA, FMEA, RCM, and risk-based asset management. Certifications: CMRP, CRE, CRL or equivalent. Experience with predictive maintenance technologies and IIoT/Industry 4.0 applications. Project Management experience, including cross-functional project leadership, scheduling, resource planning, and stakeholder management. Familiarity with Amgen-specific processes. What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

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.