Pharmaceutical Engineering Expert

hace 22 horas


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

At Qrc Group Llc, we are seeking a highly experienced Pharmaceutical Engineering Expert to lead our efforts in aseptic processing and system development. The successful candidate will have a strong background in aseptic processing, FDA product submissions, and validation activities.

Key responsibilities include:

  • Developing, implementing, and improving aseptic processes and systems to ensure high-quality production and compliance with industry standards
  • Troubleshooting and resolving issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines
  • Supporting FDA submissions with technical expertise and documentation
  • Developing, executing, and documenting validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment
  • Leading investigations for deviations and CAPAs related to aseptic operations, ensuring timely and effective resolution

Requirements:

  • Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field
  • Minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment
  • Strong knowledge of aseptic processing and systems
  • Expertise in validation methodologies (IQ/OQ/PQ) and risk management
  • Familiarity with FDA regulations, cGMP guidelines, and industry standards


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are looking for a Regulated Pharmaceutical Process Lead to join our team at Qrc Group Llc. As a key member of our organization, you will be responsible for leading efforts in designing, implementing, and improving aseptic processes and systems within a regulated pharmaceutical environment.The successful candidate will have a strong background in aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Job OverviewThe Qrc Group, Llc is seeking a highly skilled Regulatory Consultant to join our team. As a key member of our regulatory affairs department, you will provide expert guidance and support in navigating the complex regulatory landscape.About the RoleIn this critical role, you will be responsible for providing expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    Key ResponsibilitiesLead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.Develop project timelines, resource allocation plans, and budgets,...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    As a Regulatory Consultant at Qrc Group Llc, you will play a crucial role in ensuring the company's compliance with FDA regulations and guidelines. Your expertise in aseptic manufacturing and FDA product submissions will be invaluable to our team.Your key responsibilities will include providing expert regulatory advice for aseptic manufacturing processes,...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    **About the Role**Qrc Group, LLC is seeking an Aseptic Process Engineer/Lead to join our team. This role will be responsible for supporting the planning, execution, and completion of key aseptic related projects.**Responsibilities and Requirements**Support the design and implementation of aseptic manufacturing processes.Collaborate with cross-functional...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    Join Our TeamWe are a collaborative and innovative organization dedicated to delivering high-quality solutions to our clients. As a Regulatory Consultant with Qrc Group, Llc, you will have the opportunity to work with a talented team of experts who are passionate about regulatory affairs.Your Key ResponsibilitiesProvide expert regulatory advice for aseptic...


  • San Juan, San Juan, Puerto Rico Savard Group A tiempo completo

    Savard Group's Expectations: We expect our Site Engineer to possess a unique combination of technical expertise and interpersonal skills. If you are a motivated and organized individual with a passion for engineering, we encourage you to apply.Responsibilities:Project management and coordination.Leadership of MEP engineering teams.Client relationship...


  • San Juan, San Juan, Puerto Rico Enk A tiempo completo

    About the Job:We are looking for a highly skilled Building Inspection and Project Coordination Expert to join our team at Enk. This is a unique opportunity to work on exciting construction projects and contribute to the success of our company.Key Duties and Responsibilities:Carrying out thorough inspections of construction sites to ensure compliance with...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    **Job Summary:**We are seeking a highly skilled Senior Aseptic Processing Engineer to lead our efforts in designing, implementing, and improving aseptic processes and systems within a regulated pharmaceutical environment.The ideal candidate will have expertise in aseptic processing, FDA product submissions, and validation activities. Key responsibilities...


  • San Juan, San Juan, Puerto Rico Buscojobs Puerto Rico A tiempo completo

    Education & Experience:To be successful in this role, you will need at least 10 years of experience managing teams and projects. You will have proven ability to work under pressure, with excellent interpersonal skills and the ability to juggle multiple projects and responsibilities. You will proactively monitor, identify, and mitigate risks, issues, and...


  • San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

    We are seeking a highly skilled Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.The ideal candidate will have strong understanding of FDA regulations and aseptic processing guidelines.Provide expert regulatory advice for aseptic manufacturing processes,...


  • San Juan, San Juan, Puerto Rico Sos Trabajo A tiempo completo

    Job DescriptionThe ideal candidate will have a broad background in identity management, governance, and access control with expertise in platforms such as Active Directory, Okta.**Key Responsibilities:**Configure changes to IAM and PAM tools, preferably Saviynt and CyberArk.Monitor and troubleshoot the performance, availability, and security of the IAM and...


  • San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

    We are seeking an experienced Csv Specialist to join our team at Qrc Group, Llc. In this role, you will be responsible for performing validation activities on software and manufacturing equipment in the medical device industry.Responsibilities:Validating software and medical devices equipmentDeveloping and implementing validation protocolsEnsuring compliance...


  • San Juan, San Juan, Puerto Rico Buscojobs Puerto Rico A tiempo completo

    Company Overview">Popular is committed to developing and providing growth opportunities for our employees. To foster this commitment, we continually strive to expand our internal mobility options.">Job Description">Data Analytics Summer Internship (DASI) is a full-time summer experience for final year undergraduate and recent graduate students that combines...

  • Cost Estimator

    hace 3 días


    San Juan, San Juan, Puerto Rico Share Tech Group A tiempo completo

    Job Summary:">We are seeking a highly skilled Cost Estimator to join our team at Share Tech Group. As a key member of our bid proposal process, you will be responsible for accurately estimating project costs and timelines across mechanical, civil, and electrical disciplines.">The ideal candidate will possess a comprehensive understanding of construction,...


  • San Juan, San Juan, Puerto Rico Mentor Technical Group A tiempo completo

    About Mentor Technical Group">We are a leading provider of technical support and solutions to the FDA-regulated industry. Our team has extensive experience in life science engineering and technical solutions, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.">We are seeking an experienced...


  • San Juan, San Juan, Puerto Rico Uptalent A tiempo completo

    About the JobUptalent is seeking a highly skilled Civil Engineer with extensive experience in water resources design to fill a key role on our team.We are working with innovative companies worldwide, and this position will play a crucial part in designing and implementing water resources systems for clients across various industries.About YouYou will be...