Senior Aseptic Project Manager

hace 1 día


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

About the Role:

">

We are seeking an experienced Senior Aseptic Project Manager to lead and manage projects in our aseptic areas. The ideal candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries.

">

Responsibilities:

">
  • ">
  • Develop project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery">
  • Coordinate and oversee all stages of project execution from design through to FDA submission">
  • Lead complex projects related to development, commissioning, process development, and validation of aseptic pharmaceutical or medical device products">
  • Ensure compliance with FDA and other regulatory bodies' requirements">
  • Prepare and review documentation for FDA submissions">
  • Work closely with internal stakeholders to ensure cross-functional alignment and timely execution of project milestones">
  • Manage risk assessments and mitigation strategies">
">

Requirements:

">

Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred)

">

8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry

">

Proven track record of leading projects through FDA submissions

">

Strong knowledge of FDA regulations, aseptic processing, validation protocols, and good manufacturing practices (GMP)

">

Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing

">

What We Offer:

">

A competitive salary and benefits package

">

The opportunity to work on complex projects with a talented team

">

Professional development opportunities

">

Join Our Team:

">

We are committed to building a diverse and inclusive workplace culture

">

If you are a motivated and experienced project manager looking for a new challenge, please apply today



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

    Job SummaryWe are seeking an experienced Project Manager to lead our aseptic operations team. The successful candidate will have a proven track record of managing complex projects from design to FDA submission.Key ResponsibilitiesThe Senior Project Manager Lead will be responsible for:Leading and managing cross-functional teams to achieve project...


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

    Project Management ExpertiseThe Qrc Group, LLC is seeking an experienced Project Manager to join our aseptic operations team. As a Senior Project Manager Lead, you will be responsible for leading and managing complex projects from design to FDA submission.Responsibilities and RequirementsResponsibilities:Lead and manage cross-functional teams to achieve...


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

    Company OverviewThe Qrc Group, LLC is a leading provider of innovative solutions for the pharmaceutical and medical device industries.Job DescriptionJob Title: Senior Project Manager LeadReports to: Director of Aseptic OperationsLocation: Remote (with occasional on-site visits)Responsibilities:Lead and manage complex projects related to the development,...


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

    Job Description:As a Senior Aseptic Project Leader at Qrc Group Llc, you will play a crucial role in managing complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products. Your primary responsibility will be to coordinate and oversee all stages of project execution from design,...


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

    Mentor Technical Group provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. We are seeking a highly experienced Senior Construction Manager to join our team and lead our construction projects in the pharmaceutical industry.Job Summary:The Senior Construction Manager will be responsible for overseeing all...


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

    **Aseptic Process Engineer Lead - Drive Excellence in Manufacturing**Are you a seasoned aseptic process engineer looking to take your career to the next level? Join us at Qrc Group, Llc, where we strive for excellence in manufacturing and aseptic processing.Key Expectations:Develop and maintain aseptic processes and systems to ensure compliance with industry...


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

    About the Role:">We are seeking an experienced GMP Compliance Project Lead to lead and manage projects in our aseptic areas">The ideal candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries">Responsibilities:">">Develop project timelines, resource allocation plans, and budgets to...


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

    Overview:Xpt is a leading organization that requires a skilled Financial Project Manager to manage the financial aspects of projects.Key Responsibilities:Reviews project budgets and provides pre-billing information to project managers.Offers cost estimates and prepares invoices.Manages, analyzes, and reports on the financial elements of a project.Ensures...


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

    Qrc Group Llc is a leader in delivering cutting-edge digital solutions that transform businesses. We are currently seeking a Senior QA Program Manager to join our team. As a key member of our team, you will be responsible for overseeing the implementation of digital solutions, driving process performance, and enhancing operational excellence. Your expertise...


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

    Mentor Technical Group is a leading provider of technical support and solutions for the life science industry. We serve clients in six global markets, including the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.Job Overview:The Project Manager will oversee all business project management deliverables, reports,...

  • Senior IT Risk Manager

    hace 3 días


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

    About the RoleThis is an exciting opportunity to join our team as a Senior IT Risk Manager, where you will play a key role in ensuring the integrity and security of our systems.As a seasoned professional with 3+ years of experience in internal or external auditing, or information technology, preferably in financial institutions, you will be responsible for...


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

    Job OverviewThe Qrc Group, LLC is seeking a highly skilled and experienced Senior Process Engineer to lead efforts in the design, commissioning, implementation, and improvement of aseptic processes and systems. As an expert in aseptic processing, you will ensure high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA).Key...


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

    We are seeking a highly experienced Project Manager to join our team at Mentor Technical Group. As a world leader in life science engineering and technical solutions, we provide comprehensive portfolio of technical support and solutions for the FDA-regulated industry.Job Description:The Project Manager will be responsible for overseeing all aspects of...


  • San Juan, San Juan, Puerto Rico The Condado Plaza Hotel A tiempo completo

    Job OverviewWe are seeking a highly motivated and detail-oriented Senior Hotel Maintenance Manager to join our team at The Condado Plaza Hotel. As a key member of our engineering department, you will be responsible for ensuring the smooth operation of our hotel's mechanical, electrical, and HVAC systems.Key ResponsibilitiesPerform regular inspections of the...


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

    Company Overview:The Qrc Group Llc is a leading organization in the pharmaceutical and medical device industry, renowned for its commitment to excellence and innovation. Our team of experts is dedicated to delivering high-quality products that meet the stringent regulatory requirements.


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

    At Qrc Group Llc, we are seeking a highly skilled Sr. Engineer to lead our efforts in designing, implementing, and improving aseptic processes and systems.Key Responsibilities:Develop and execute validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment.Lead investigations for deviations and CAPAs related to aseptic...


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

    Overview:">Qrc Group, LLC is a leading provider of contract manufacturing services to the pharmaceutical and medical device industries">We are seeking an experienced Regulated Pharmaceutical Projects Director to lead and manage projects in our aseptic areas">Job Description:">The Regulated Pharmaceutical Projects Director will be responsible for developing...


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

    **About Peoplelift**We are an innovative construction management company based in San Juan, Puerto Rico. Our team is dedicated to delivering exceptional results for our clients through our expertise and commitment to safety.About the Role:We are seeking an experienced Construction Project Manager to lead our commercial and mixed-use development projects in...


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

    About PeopleliftWe are a dynamic construction management company based in San Juan, Puerto Rico. Our team is committed to delivering exceptional results for our clients through our expertise and commitment to safety.Job Description:We are seeking an experienced Project Manager to lead our commercial and mixed-use development projects in the San Juan...


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

    Job Description\At Heartland Consulting, we are dedicated to providing exceptional service to our clients and communities. As a Disaster Recovery Lead, you will play a critical role in helping us achieve this mission.\Our ideal candidate will have a strong background in disaster recovery, with experience managing complex projects and teams. They will possess...