Engineer

hace 4 semanas


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Under general supervision, the Operations/Design Engineer is responsible for providing solutions to operational and engineering issues in the manufacturing, pilot plant, or capital projects environment.
The role involves applying basic engineering principles to design, modify, and implement system changes, troubleshoot operational problems, and optimize processes.
The engineer will work on both operational troubleshooting and design engineering projects, often interacting with various departments such as research, manufacturing, maintenance, and quality assurance.
This position requires a hands-on approach to equipment optimization, system design, and ensuring compliance with regulatory standards.
Key Responsibilities: Technical Problem Solving & Operations Engineering: Provide solutions to a variety of moderate scope technical problems, applying standard engineering techniques and procedures.
Investigate operational issues and design experiments or modifications to resolve them.
Audit the operational performance and regulatory compliance of equipment systems of significant complexity.
Serve as a technical expert for troubleshooting operations and actively assist in daily operations to meet schedules or resolve complex issues.
Work with cross-functional teams (research, manufacturing, quality assurance, etc.)
to develop recommendations for system modifications.
Design Engineering: Under direct supervision, assist in completing design, engineering, and construction projects within schedule and budget constraints.
Collaborate with consultants, architects, and engineering firms to develop standard design documents and technical specifications.
Obtain and evaluate quotes for equipment modifications or installations.
Generate project cost estimates and schedules for minor to moderate scope projects.
Support the design and implementation of system improvements.
Equipment and Systems Optimization: Lead initiatives to enhance system reliability, focusing on equipment availability, downtime reduction, and maintenance optimization.
Collaborate with engineering teams to determine the best maintenance strategy for manufacturing equipment.
Develop and track equipment performance metrics (e.g., availability, downtime) and identify improvement opportunities.
Act as Subject Matter Expert (SME) for system design, maintenance, and compliance operations.
Support troubleshooting efforts and process deviations for equipment issues within the assigned functional area.
Regulatory Compliance and Documentation: Ensure that all engineering work adheres to GMP, GLP, and other applicable regulatory standards.
Assist in the creation and review of technical documentation, including validation protocols and reports.
Participate in validation protocol execution and support compliance with regulatory requirements.
Define, implement, and manage corrective actions (CAPAs) related to equipment within the area of expertise.
Safety & Environmental Compliance: Contribute to Environmental, Health, and Safety (EHS) compliance within engineering and operational activities.
Support the implementation of safety measures in both engineering projects and operational processes.
Preferred Experience/Skills: Working knowledge of pharmaceutical/biotech processes and validation practices.
Familiarity with documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computer systems.
Experience with CMMS systems for manufacturing equipment (work orders, PM strategy, spare parts, etc.).
Ability to interpret and apply GMP, GLP, and regulatory standards.
Strong technical problem-solving and applied engineering skills.
Experience in developing and implementing equipment performance metrics (availability, downtime, etc.).
Ability to write basic technical reports and perform technical presentations.
Knowledge of validation protocol writing and execution.
Strong verbal and written communication skills.
Requirements Qualifications: Master's degree or in Engineering (Mechanical, Electrical, Chemical, etc.)
with a minimum of 2 years of engineering experience.
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, etc.)
with a minimum of 2 years of engineering experience.
Additional Attributes (Preferred Qualifications): Experience with equipment ownership and maintenance in CMMS systems.
Ability to drive change and implement improvements in equipment reliability and performance.
Expertise in managing equipment-related deviations and CAPAs.
Benefits Administrative Shift


  • Engineer

    hace 4 semanas


    Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    An Engineer with experience providing support to manufacturing activities, knowledge in chromatography and filtration systems. Knowledge in PI historian, statistical analysis and protein purification techniques.Requisitos:Master's degree or Bachelor's degree in Engineering & 2 years of Engineering experience.Bilingual (Spanish/English)(Write/Speak)Computer...

  • Engineer

    hace 4 semanas


    Juncos, Puerto Rico Qrc Group, Llc A tiempo completo

    Job Description An Engineer with experience providing support to manufacturing activities, knowledge in chromatography and filtration systems.Knowledge in PI historian, statistical analysis and protein purification techniques.Requirements Master's degree or Bachelor's degree in Engineering & 2 years of Engineering experience.Bilingual...

  • Sr Engineer

    hace 2 semanas


    Juncos, Puerto Rico Qrc Group, Llc A tiempo completo

    Job Description Sr Engineer with  experience working directly for a biotechnology or pharmaceutical industry a project engineering environment.Work with Manufacturing to develop user requirements for capital projects.Develop project schedule of installation and qualification activities.Work directly with construction and C&Q contractors to deliver project...

  • Sr Engineer

    hace 2 semanas


    Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    Sr Engineer with experience working directly for a biotechnology or pharmaceutical industry a project engineering environment.Work with Manufacturing to develop user requirements for capital projects.Develop project schedule of installation and qualification activities.Work directly with construction and C&Q contractors to deliver project...

  • Engineer

    hace 4 semanas


    Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    An engineer capable of resolving equipment-related problems by using technical skills to analyze the condition, understand variables that impact the process, and propose and resolve issues. Resource should understand control systems (input, output, control). Experience in drug substance/API operations. Preferred experience in equipment start up,...

  • Engineer

    hace 4 semanas


    Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    An engineer capable of resolving equipment-related problems by using technical skills to analyze the condition, understand variables that impact the process, and propose and resolve issues. Resource should understand control systems (input, output, control). Experience in drug substance/API operations. Preferred experience in equipment start up,...


  • Juncos, Puerto Rico Quality Consulting Group A tiempo completo

    About Our TeamWe are a dynamic team of professionals dedicated to delivering exceptional quality services to our clients.Job OverviewWe are seeking an experienced Equipment Maintenance Engineer to join our team. The successful candidate will be responsible for executing maintenance activities, operating equipment, and troubleshooting mechanical issues.Key...


  • Juncos, Puerto Rico Cis International Llc A tiempo completo

    **Job Overview**We are seeking an experienced Software Development Engineer to join our team at Cis International Llc. In this role, you will be responsible for developing and implementing complex engineering techniques and procedures.As a seasoned engineer, you will have the opportunity to work on novel assignments, develop new engineering policies and...


  • Juncos, Puerto Rico Quality Consulting Group A tiempo completo

    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: Independently...


  • Juncos, Puerto Rico Cis International Llc A tiempo completo

    Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.Develop engineering policies and procedures that affect multiple organizational units.Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project...

  • Process Engineer

    hace 4 semanas


    Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

    Under general supervision, the Process Engineer provides characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital projects environments.This role applies basic engineering principles to the design and implementation of system modifications, experiments, and/or...


  • Juncos, Puerto Rico Cis International Llc A tiempo completo

    Cis International Llc requires a highly skilled Utility Systems Engineer to maintain and operate plant support equipment, troubleshoot complex issues, and provide detailed training programs to develop one's knowledge in the maintenance and operations field.Some of your key responsibilities will include:Maintaining and operating plant support...


  • Juncos, Puerto Rico Biopharma Consulting Services A tiempo completo

    At Biopharma Consulting Services, we are seeking a skilled Data Validation Engineer to provide technical validation engineering support for process and equipment upgrades, replacements, and modifications in our laboratory, manufacturing or manufacturing support environment.We require candidates with a strong engineering or scientific background, preferably...

  • Sr. Engineer

    hace 2 semanas


    Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    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...

  • Sr Engineer

    hace 4 semanas


    Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

    The Senior Process Engineer independently provides and/or directs the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital projects environments.The role involves applying advanced engineering principles to design and implement major system modifications,...


  • Juncos, Puerto Rico Cis International Llc A tiempo completo

    Job Description:Cis International Llc is seeking a highly motivated and detail-oriented Manufacturing Systems Engineer to join our team. This role will be responsible for monitoring the operations of unit operations or systems, assisting with maintenance and project personnel, and auditing the operational performance and regulatory compliance of equipment...

  • Process Engineer

    hace 3 semanas


    Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

    We are seeking a Process Engineer with a background in Mechanical Engineering, Biotechnology, or Chemical Engineering to support process optimization, troubleshooting, and system modifications in a pharmaceutical/biotech manufacturing environment.The ideal candidate will apply engineering principles to enhance operations, evaluate system performance, and...


  • Juncos, Puerto Rico Cis International Llc A tiempo completo

    About Cis International LlcCis International Llc is a leading company in the industry, dedicated to providing innovative solutions for manufacturing systems. We are currently seeking a highly skilled and motivated individual to join our team as a Manufacturing Systems Engineer.Job SummaryWe are looking for an experienced professional who can perform standard...

  • Manufacturing Engineer

    hace 4 semanas


    Juncos, Puerto Rico Eqval A tiempo completo

    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.The...

  • Sr. Engineer

    hace 2 semanas


    Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    For engineering services in the manufacturing and Capital Projects  a rea.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree with five (5) years of exposure as an Engineer within the pharmaceutical or regulated industry.Bilingual (English & Spanish).Project Management skills.Shift: Administrative and according to business needs.Experience...