GMP Equipment Engineering Lead

3 weeks ago

Marquand, Missouri, United States Novartis Group Companies Full time

Job Overview

At Novartis Group Companies, we are dedicated to pioneering advancements in nuclear medicine and providing innovative radioligand therapy (RLT) solutions for cancer patients.

We are seeking a qualified individual to lead the equipment and Commissioning, Qualification, and Validation (CQV) engineering team at our GMP Radioligand Therapies Isotope Production Facility. This role involves acting as the Equipment & CQV Workstream Lead on significant site capital projects, overseeing the commissioning, qualification, and operational readiness of GMP production equipment.

Key Responsibilities:

  • Lead a team of GMP equipment asset owners, managing the entire GMP lifecycle from User Requirement Specifications (URS) to CQV and ensuring equipment is operationally ready.
  • Oversee a team of CQV/CSV and Equipment Engineers to ensure equipment reliability while adhering to all relevant quality and Health, Safety, and Environmental (HSE) regulations.
  • Foster a strong quality and compliance culture, ensuring timely resolution of Equipment Engineering and CQV-related cGMP deficiencies.
  • Manage capital projects focused on equipment upgrades, including planning, execution, and documentation.
  • Provide regular updates to management regarding project progress, priorities, and timelines.
  • Coordinate with external vendors and contractors to meet business requirements.
  • Author and manage CQV plans, qualification protocols, and related documentation.
  • Drive continuous improvement initiatives to achieve world-class standards and operational excellence.
  • Recruit, train, and develop a team of qualified professionals, fostering their growth and development.
  • Oversee the complete CQV & CSV program, ensuring compliance with all qualification standards and maintaining validated states.
  • Act as a subject matter expert (SME) to support internal and external inspections.
  • Manage capital project budgets and support site cost improvement initiatives.
  • Assist in the development of CQV & CSV policies and procedures to ensure compliance with corporate and regulatory standards.
  • Support site operations on a 24/7 basis post-startup.
  • Perform other related duties as assigned.

Qualifications:

  • Bachelor's degree in engineering, computer science, automation, or a related field.
  • A minimum of 5 years of relevant engineering experience in the Chemical or Pharmaceutical industry.
  • Proven experience in hiring, managing, and developing technical resources in a GMP environment.
  • Comprehensive knowledge of FDA regulations, particularly 21 CFR part 11, GAMP5, and GMP systems.
  • Strong oral and written communication skills.
  • Willingness to travel 5-10% as needed.

Compensation:

The anticipated salary range for this position is between $124,000 and $186,000 annually, with variations based on individual factors such as market location, job-related knowledge, skills, and experience. The total compensation package may also include additional elements such as sign-on bonuses, stock options, and a comprehensive benefits package.

Commitment to Diversity & Inclusion:

Novartis is dedicated to fostering an inclusive work environment and building diverse teams that reflect the communities we serve.

EEO Statement:

Novartis Group Companies are Equal Opportunity Employers and maintain a diverse environment, ensuring no discrimination in recruitment, hiring, training, or promotion based on legally protected statuses.

  • GMP Equipment Engineering Lead

    3 weeks ago

    Marquand, Missouri, United States Novartis Farmacutica Full time

    About Novartis: At Novartis Farmacutica, we are dedicated to pioneering advancements in nuclear medicine, focusing on the next generation of targeted radioligand therapy (RLT) for cancer patients.Position Overview: We are seeking a highly skilled professional to oversee the equipment and CQV engineering team at our GMP Radioligand Therapies Isotope...

  • Senior Equipment Engineer

    1 week ago

    Marquand, Missouri, United States Novartis Group Companies Full time

    Job Summary:We are seeking a highly skilled Senior Equipment Engineer to lead our GMP equipment lifecycle management team at the Novartis Group Companies. As a key member of our team, you will be responsible for ensuring the reliability and compliance of our GMP equipment, from commissioning to operational readiness.Key Responsibilities:Equipment Lifecycle...

  • Lead Automation Engineer

    3 weeks ago

    Marquand, Missouri, United States Novartis Group Companies Full time

    Position OverviewThe Lead Automation Engineer plays a crucial role in overseeing automation systems, interfaces, and equipment within the organization. This position is responsible for the management of automation systems throughout the facility, ensuring adherence to internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external...

  • GMP Operations Manager

    1 week ago

    Marquand, Missouri, United States SBM Management Services Full time

    Job SummarySBM Management Services is seeking a highly skilled GMP Supervisor to oversee the coordination of activities within the assigned areas of the Good Manufacturing Practices (GMP) program. The successful candidate will be responsible for ensuring compliance with sanitation, OSHA regulations, and site-specific Standard Operating Procedures (SOPs).Key...

  • Lead Facilities Engineer

    3 weeks ago

    Marquand, Missouri, United States Novartis Farmacéutica Full time

    About Novartis:At Novartis Farmacéutica, we are dedicated to pioneering advancements in nuclear medicine, focusing on the development of targeted radioligand therapies (RLT) for cancer treatment.Position Overview:The Lead Facilities Engineer plays a crucial role in ensuring the optimal performance and enhancement of the site’s infrastructure and utility...

  • Production Engineer

    2 weeks ago

    Marquand, Missouri, United States Heartland Food Products Group Full time

    Job SummaryWe are seeking a highly skilled Production Engineer to join our team at Heartland Food Products Group. As a key member of our operations team, you will be responsible for driving improvement in equipment reliability and overall line performance.Key ResponsibilitiesEquipment Operations: Operate the production line with an ownership mentality,...

  • GMP Operations Manager

    6 days ago

    Marquand, Missouri, United States SBM Management Services Full time

    Job SummarySBM Management Services is seeking a highly skilled GMP Operations Manager to oversee the coordination of activities within the assigned areas of the GMP program. The successful candidate will be responsible for ensuring compliance with sanitation, OSHA regulations, and site-specific SOPs.Key ResponsibilitiesCoordinate and monitor work activities,...

  • Capital Project Engineer

    2 weeks ago

    Marquand, Missouri, United States Novartis Group Companies Full time

    Job Summary:Novartis Group Companies 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's leadership team, you will be responsible for commissioning, qualification, and start-up of GMP production equipment, ensuring...

  • Lead Manufacturing Engineer

    3 weeks ago

    Marquand, Missouri, United States BioSpace, Inc. Full time

    Position OverviewAt BioSpace, Inc., we are dedicated to enhancing lives through innovative healthcare solutions. As a prominent player in the biopharmaceutical industry, we strive to discover and deliver transformative therapies that improve patient outcomes globally. Our workforce is committed to excellence, and we prioritize the well-being of our...

  • Lead Process Improvement Engineer

    2 weeks ago

    Marquand, Missouri, United States Heartland Food Products Group Full time

    Overview:The Senior Manufacturing Process Engineer plays a pivotal role in delivering technical assistance for production and process systems aimed at enhancing overall equipment efficiency and operational excellence. This position collaborates closely with quality assurance and engineering teams to facilitate efficiencies and the integration of new products...

  • Equipment Maintenance Specialist

    2 days ago

    Marquand, Missouri, United States Path Engineering Full time

    RoleAs a Maintenance Technician at Path Engineering, you will be responsible for ensuring equipment uptime through timely and in-depth troubleshooting and repair. You will maintain and repair all production equipment, perform troubleshooting and repair of facilities and auxiliary equipment, and work closely with Machine Operators, Supervisors, and Senior...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Marquand, Missouri, United States Novartis Full time

    Position Overview At Novartis, we are at the forefront of innovation in nuclear medicine, dedicated to advancing targeted radioligand therapy (RLT) for cancer patients. We seek a seasoned professional in the pharmaceutical sector with expertise in validation, maintenance, engineering, or quality assurance to join our team at a new manufacturing facility....

  • Plant/Project Engineer

    1 week ago

    Marquand, Missouri, United States Eli Lilly Full time

    About the RoleWe are seeking a highly skilled Project Manager to join our Facilities, Utilities, Maintenance, and Engineering (FUME) group. As a key member of our team, you will be responsible for leading multi-disciplinary teams to develop and execute project goals, ensuring timely and within-budget delivery.Key ResponsibilitiesProject Leadership: Drive...

  • GMP Production Technician

    3 weeks ago

    Marquand, Missouri, United States Net2Source Inc. Full time

    Position: Production TechnicianLocation: Indianapolis, INDuration: 06+ Months (Extendable)Pay Rate: $30.79/hr on W2Qualifications:Minimum of 5 years of experience in a manufacturing setting is required. Familiarity with Good Manufacturing Practices (GMP) is essential, along with strong multitasking abilities, technical skills, and troubleshooting...

  • Engineering and Maintenance Director

    4 days ago

    Marquand, Missouri, United States Affinity Executive Search Full time

    About the RoleWe are seeking a highly skilled and experienced Engineering and Maintenance Manager to join our client's team. As a key member of the organization, you will be responsible for maintaining and improving equipment reliability, process engineering, automation, controls, employee workforce development, and equipment upgrades and design.Key...

  • Manager of Engineering and Maintenance Operations

    3 weeks ago

    Marquand, Missouri, United States First Search Inc. Full time

    Manager of Engineering and Maintenance OperationsFirst Search Inc., a dynamic player in the manufacturing sector, is on the lookout for a committed professional to fill the role of Manager of Engineering and Maintenance Operations. This pivotal position is responsible for managing equipment reliability, process optimization, automation, control systems,...

  • Engineering and Maintenance Director

    2 days ago

    Marquand, Missouri, United States First Search Inc. Full time

    Engineering and Maintenance ManagerFirst Search Inc. is seeking a highly skilled Engineering and Maintenance Manager to join our team. As a key member of our organization, you will be responsible for maintaining and improving equipment reliability, process engineering, automation, controls, employee workforce development, and equipment upgrades and...

  • Telecoms Equipment Configuration Expert

    2 weeks ago

    Marquand, Missouri, United States Extreme Engineering Full time

    Job Summary:Extreme Engineering is seeking a highly skilled Nokia Network Installation Specialist to join our team. As a key member of our infrastructure team, you will be responsible for installing and configuring various network equipment, including Nokia 7750-SR1, 7750-SrA8, 7210, 7250-IXR-E/S, and other related systems.Key Responsibilities:Install and...

  • Production Operations Lead

    3 weeks ago

    Marquand, Missouri, United States Ingredion Full time

    POSITION:Process LeadLOCATION:IndianapolisREPORTS TO:Unit ManagerThe Process Lead serves as a key technical resource, leveraging expertise in process and manufacturing methodologies. This role is pivotal in the formulation and execution of production strategies, troubleshooting, and continuous enhancement initiatives aimed at maximizing operational...

  • Principal Process Engineer

    1 week ago

    Marquand, Missouri, United States Eli Lilly Full time

    About the RoleWe are seeking a highly skilled Process Engineer to join our Bioprocess Development team at Eli Lilly. As a key member of our team, you will be responsible for providing engineering support to the maintenance and operations groups in our Clinical Trials Manufacturing Facility.Key ResponsibilitiesProvide engineering support in the pilot plant,...