Aseptic Process Engineer/Lead

hace 8 horas


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

Aseptic Process Engineer/Lead to design and support the aseptic manufacturing processes at designated locations.
Responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation investigations and change management. Able to work cross-functionally with Quality, Operation, Maintenance, Validation, and Sterility Assurance to deliver key milestones for projects.

Responsibilities:

Responsible for technical support of formulation, aseptic filling and sealing operations.
Leads and supports Aseptic process simulations.
Conducts and writes formal investigation reports with the assistance of plant personnel.
Requisitos:
Bachelors Degree in a technical field required. Minimum of 5 years experience in aseptic pharmaceutical manufacturing and/or quality environment required.
Requires thorough knowledge of GMPs and understanding in aseptic processing.
Bilingual (Spanish/English).



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

    Aseptic Process Engineer/Lead plays a crucial role in Qrc Group Llc’s operations, overseeing the design and support of aseptic manufacturing processes at designated facilities. Key responsibilities include planning, execution, tracking, and completion of key projects related to production process/systems implementation, shut down/restart process, media...


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

    We are looking for a skilled Aseptic Manufacturing Specialist to support our team at Qrc Group Llc. The successful candidate will have a strong background in regulatory affairs and aseptic manufacturing.### Key Responsibilities:Develop and implement aseptic manufacturing processes that meet FDA and global regulatory standards.Collaborate with...

  • Project Manager

    hace 1 día


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

    Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.Responsibilities:Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.Coordinate and oversee all stages of project...


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

    At Qrc Group Llc, we are seeking a seasoned Director of Aseptic Operations to oversee and manage projects in our aseptic areas.Key Responsibilities:Develop project timelines, resource allocation plans, and ensure timely and on-budget deliveryCoordinate and oversee all stages of project execution from design through to FDA submissionRequirements:Bachelor's...


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

    Qrc Group Llc is seeking a Regulated Project Management Lead to oversee and manage projects in our aseptic areas.Key Responsibilities:Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget deliveryCoordinate and oversee all stages of project execution from design, development, and validation through to FDA...


  • San Juan, San Juan, Puerto Rico Solvenow Inc. A tiempo completo

    Job OverviewSolvenow Inc. is seeking a highly skilled Civil/Structural Engineer to join our team. As a key member of our engineering department, you will apply your knowledge of civil/structural engineering principles and practices in broad areas of assignments and related fields.Key ResponsibilitiesParticipate on multidisciplinary teams in an office...

  • Digital Project Lead

    hace 5 días


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

    At Qrc Group Llc, we are seeking a highly experienced Digital Project Lead to oversee projects focused on the implementation of digital and AI solutions that drive process performance and enhance operational excellence.The ideal candidate will have experience in regulated industries, ensuring compliance with regulatory and quality standards across processes,...

  • Operations Lead

    hace 8 horas


    San Juan, San Juan, Puerto Rico Fulcro Talent Acquisition A tiempo completo

    About People Talent At People Talent, we specialize in connecting highly skilled professionals.Our mission is to bridge the gap between exceptional talent and the organizations that need it, fostering growth and success for both parties.Whether you are a company seeking C-level candidates or a professional looking to take the next step in your career, People...

  • Regulatory Consultant

    hace 1 día


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

    Regulatory Consultant will provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.Responsibilities: Provide expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.Prepare and review regulatory submissions to the FDA,...


  • San Juan, San Juan, Puerto Rico Heartland Consulting A tiempo completo

    Job OverviewWe are seeking a highly skilled Grant Analyst Team Lead to join our team at Heartland Consulting. The ideal candidate will have experience in auditing federally funded grant programs and possess strong leadership, compliance, and analytical skills.Key ResponsibilitiesSupport the Project Manager in daily operations and assigned...


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

    We are looking for a Senior Manager of Pharmaceutical Projects to join our team at Qrc Group Llc.Job Summary:Lead and manage projects related to the development, commissioning, and validation of aseptic pharmaceutical productsKey Qualifications:PMP certified preferableStrong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic...


  • San Juan, San Juan, Puerto Rico Heartland Consulting A tiempo completo

    Job Title: Grant Analysts Team Lead Location: Puerto Rico (Local Candidates Only) Job Type: Full-Time Position Overview: We are seeking a highly skilled Grant Analysts Team Lead to join our team.The ideal candidate will have experience in auditing federally funded grant programs and possess strong leadership, compliance, and analytical skills.This role...


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

    **Job Overview:**We are seeking a highly skilled Regulatory Consultant to join our team at Qrc Group Llc. This individual will provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.### Responsibilities:Provide Regulatory Advice: Offer expert regulatory advice for aseptic manufacturing...


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

    Job TypeFull:time ColombiaGeneral DescriptionPerform assessment and accreditation efforts before releasing new systems to production.This role is highly cross:functional and requires working within Information Security, with IT division and other divisions across the company.Essential Duties and Responsibilities:Assist in defining and establishing...

  • Qa Project Manager

    hace 5 días


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

    QA Project Manager with experience in regulated industry.Duties:Oversee projects focused on implementation of digital and AI solutions that drive process performance and enhance operational excellence.Lead initiatives related to data integrity compliance ensuring compliance with regulatory and quality standards across processes, systems, and...


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

    We are looking for a Quality Assurance Manager to lead our efforts in implementing digital and AI solutions that drive process performance and enhance operational excellence at Qrc Group Llc.The ideal candidate will have a strong background in regulated industries, ensuring compliance with regulatory and quality standards across processes, systems, and...


  • San Juan, San Juan, Puerto Rico Heartland Consulting A tiempo completo

    About the RoleWe are seeking a seasoned Grant Analyst Team Lead to lead our team at Heartland Consulting. This is an excellent opportunity for individuals who possess expertise in auditing federally funded grants and want to leverage their skills in a fast-paced environment.ResponsibilitiesServe as a key member of the Project Management team, providing...


  • San Juan, San Juan, Puerto Rico Heartland Consulting A tiempo completo

    Job SummaryThe Grant Analyst Team Lead will be responsible for leading a team of Grant Analysts at Heartland Consulting. This role requires a high level of expertise in grant program auditing, leadership, and compliance.DutiesSupport the Project Manager in daily operations and assigned responsibilities, ensuring seamless execution of projects.Review and...

  • Utility Operator

    hace 5 días


    San Juan, San Juan, Puerto Rico Integrated Power Services A tiempo completo

    At IPS, we're all about exceptional service and exceptional people.We're looking for a passionate In-Shop Technician who loves hands-on work, takes pride in their craft, and wants to have a meaningful impact.As an In-Shop Technician, every day will be different.You'll get to apply your knowledge and skills to solve complex problems and help critical...

  • Program Coordinator

    hace 5 días


    San Juan, San Juan, Puerto Rico Dcmc Partners A tiempo completo

    Job Title: Program Coordinator - Multi Site Construction (Client Representative) Location: Various locations in Puerto Rico Position Type: Full-Time, Project-specific About DCMC Partners DCMC Partners, a Great Place to Work Certified company, specializes in disaster recovery, hazard mitigation, and crisis management with over 30 years of expertise .We...