Site Equipment Specialist

3 weeks ago


Marquand, Missouri, United States Novartis Group Companies Full time

Job Summary

Novartis is seeking a highly skilled and experienced professional to lead the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. As the Equipment & CQV Workstream Lead, you will be responsible for commissioning, qualification, and start-up of the GMP production equipment through to operational readiness.

Key Responsibilities

  • Manage a team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensure compliance with all applicable quality and HSE regulations and requirements.
  • Promote a strong quality and compliance mindset, supporting timely closure of Equipment Engineering & CQV related cGMP deficiencies, including audit observations, CAPAs, and deviations.
  • Manage capital projects involving equipment upgrades, including planning, execution, and documentation.
  • Provide timely reporting to management on progress, priorities, timelines, and sharing of necessary information.
  • Contract and manage outside vendors and contractors to fulfill business needs.
  • Author and/or manage authoring of CQV plans, qualification protocols, qualification summary reports, and requirement trace matrices.
  • Drive continuous improvement to meet world-class standards using operational excellence principles and develop best practices.
  • Oversee recruitment, training, and manage qualified professionals, coaching, developing, and growing talent within the team.
  • Manage the complete CQV & CSV program, from site VMP, compliance with all qualification standards, through to periodic review, and ensure a validated state is maintained.
  • Develop a risk-based qualification approach and strategy, including FMEA, Risk Assessments, PHA, etc.
  • Act as a subject matter expert (SME) at the site to support internal and/or external inspections.
  • Manage capital project capex and qualification team budgets and support site cost improvement initiatives.
  • Support the development of CQV & CSV policies and procedures to maintain compliance with site, corporate, and regulatory standards.
  • Support 24x7 site-based operations after startup.

Requirements

  • Bachelor's degree in engineering, computer science, automation, or a related field is required.
  • 5+ years of relevant engineering experience in the Chemical or Pharmaceutical industry is required.
  • Experience hiring, managing, and developing technical resources in an operating GMP environment is required.
  • In-depth knowledge of FDA regulations, particularly 21 CFR part 11, GAMP5, and GMP systems, is required.
  • Excellent oral and written communication skills are required.

  • Site Equipment Lead

    3 weeks ago


    Marquand, Missouri, United States Novartis Group Companies Full time

    Job SummaryAs a Site Equipment Lead at Novartis, you will be responsible for leading the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. You will act as Equipment & CQV Workstream Lead on a major site capital project with responsibility for commissioning, qualification and start-up of the GMP production...


  • Marquand, Missouri, United States Novartis Group Companies Full time

    Job SummaryNovartis is seeking a highly skilled Site Equipment Manager to lead the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. As a key member of the site leadership team, you will be responsible for commissioning, qualification, and start-up of GMP production equipment, ensuring operational readiness and...


  • Marquand, Missouri, United States Tristate Equipment Full time

    Service Technician Job DescriptionWe are seeking a skilled Service Technician to join our team at Tristate Overhead Crane. As a Service Technician, you will be responsible for running electrical and mechanical diagnostics and delivering required repairs onsite at customer locations.Key Responsibilities:Troubleshoot and repair overhead cranes, crane controls,...

  • Site Specialist

    3 weeks ago


    Marquand, Missouri, United States Thermo Fisher Scientific Full time

    Job Title: Site Specialist - Laboratory ServicesAs a Site Specialist - Laboratory Services at Thermo Fisher Scientific, you will play a critical role in delivering exceptional customer service and laboratory services to our clients. This is an exciting opportunity to join a dynamic team and contribute to the success of our organization.Key...


  • Marquand, Missouri, United States Adecco US, Inc. Full time

    Adecco US, Inc. is a leading provider of human resource solutions, and we are seeking a dedicated Industrial Equipment Service Specialist to join our team in the Indianapolis, IN area. This is a Direct Hire opportunity with a competitive salary ranging from $70,000 to $85,000 per year.Job Summary:The Industrial Equipment Service Specialist will be...


  • Marquand, Missouri, United States Actalent Full time

    Job Title: Industrial Equipment Calibration SpecialistJob DescriptionThis client is a calibration services company that supports life sciences companies across the nation. These teams will sit onsite with Eli Lilly, supporting the new equipment calibration for the new Lilly center in Lebanon. You will work with other calibration engineers and technicians and...

  • Lead Site Specialist

    3 weeks ago


    Marquand, Missouri, United States Thermo Fisher Scientific Full time

    Job DescriptionAs a key member of the Thermo Fisher Scientific team, you will play a critical role in ensuring the success of our laboratory operations. We are seeking a highly motivated and experienced Lead Site Specialist to join our team.Key ResponsibilitiesDirect the daily workflow for a small team under the direction of the site lead and/or...


  • Marquand, Missouri, United States MacAllister Rentals Full time

    At MacAllister Rentals, we are seeking a skilled Equipment Maintenance Specialist to join our team. This role involves performing efficient and thorough mechanical repairs and maintenance of rental equipment primarily at customer job sites and occasionally in the shop.The ideal candidate will have 5 years or more of work-related experience in a technician...

  • Lead Site Specialist

    3 weeks ago


    Marquand, Missouri, United States Thermo Fisher Scientific Full time

    Job DescriptionAs a key member of the Thermo Fisher Scientific team, you will play a critical role in enabling our customers to make the world healthier, cleaner, and safer.Key ResponsibilitiesDirect the daily workflow for a small team under the direction of the site lead and/or supervisor.Oversee service offerings including order/stockroom/dock management,...


  • Marquand, Missouri, United States Army National Guard Full time

    Job Summary As an Electrical Equipment Specialist in the Army National Guard, you will be responsible for maintaining and repairing electrical systems and equipment. Your primary duties will include inspecting and repairing electrical equipment, replacing worn gaskets and sealing in watertight electrical equipment, and maintaining and repairing gasoline...


  • Marquand, Missouri, United States Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Site Specialist Lead to join our team at Thermo Fisher Scientific. This role will direct the daily workflow for a small team under the direction of the site lead and/or supervisor, enabling the team to consistently deliver high levels of customer service in support of our contractual obligations.Key...


  • Marquand, Missouri, United States Superior Van & Mobility Full time

    We are seeking a skilled Automotive Equipment Repair Specialist to join our team at Superior Van & Mobility in Indianapolis. This role offers a Monday through Friday schedule and a competitive hourly rate, plus monthly bonus opportunities. Our certified team is dedicated to providing the highest quality of service and finding the right solution for our...


  • Marquand, Missouri, United States Novartis Group Companies Full time

    Job Description SummaryWe are seeking an experienced Quality professional to support site start-up and Quality operations at our new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis. As the Site Quality Head, you will provide quality assurance oversight and technical and strategic leadership for all quality-related matters.Key...


  • Marquand, Missouri, United States BRAMCO GROUP Full time

    Job Title: Compact Equipment Sales RepresentativeAt Bramco Group, we are seeking a highly motivated and experienced Compact Equipment Sales Representative to join our team. As a key member of our sales department, you will be responsible for developing and maintaining a strong customer base, promoting the sales of compact equipment lines, and ensuring...


  • Marquand, Missouri, United States Novartis Group Companies Full time

    Job SummaryWe are seeking an experienced Quality professional to support site start-up and Quality operations at our new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis. As the Site Quality Head, you will provide quality assurance oversight and technical and strategic leadership for all quality-related matters.Key...

  • Shop Mechanic

    2 weeks ago


    Marquand, Missouri, United States MacAllister Machinery Full time

    Job Summary: MacAllister Machinery is seeking a skilled Shop Mechanic to join our team. As a Shop Mechanic, you will be responsible for performing mechanical services on equipment, including new and rental equipment, for the Service Department at job sites or in the shop. Key Responsibilities: Diagnose and repair equipment malfunctions and failures,...

  • Site Technician

    4 weeks ago


    Marquand, Missouri, United States Konecranes Full time

    Job Title: Site TechnicianKonecranes is seeking a skilled Site Technician to join our team. As a Site Technician, you will be responsible for performing inspections, maintenance, and repairs on electric overhead traveling cranes and hoists at varied customer locations.Key Responsibilities:Conduct on-site electrical, mechanical, structural, and electronic...

  • Site Technician

    3 weeks ago


    Marquand, Missouri, United States Konecranes Full time

    About KonecranesKonecranes is a global leader in material handling solutions, serving a broad range of customers across multiple industries. We consistently set the industry benchmark, from everyday improvements to the breakthroughs at moments that matter most, because we know we can always find a safer, more productive and sustainable way.Job Position: Site...


  • Marquand, Missouri, United States BBC Pump and Equipment Company, Inc. Full time

    At BBC Pump and Equipment Company, Inc., we are seeking a skilled Pump and Boiler Maintenance Specialist to join our team of experienced engineers.The ideal candidate will have a strong background in pump and boiler installation, maintenance, and repair, as well as knowledge of commercial and industrial hydronic HVAC systems.Responsibilities will...

  • Site Technician

    3 weeks ago


    Marquand, Missouri, United States Konecranes Nuclear Equip and Services LLC Full time

    Job Title: Site TechnicianWe are seeking a skilled Site Technician to join our team at Konecranes Nuclear Equip and Services LLC. As a Site Technician, you will be responsible for performing inspections, maintenance, and repairs on electric overhead traveling cranes and hoists at various customer locations.Key Responsibilities:Conduct on-site electrical,...