Current jobs related to Validation Engineer - Summit - System One Holdings, LLC

  • Validation Support

    2 months ago

    Summit, United States System One Full time

    Job Title: Validation support Location: Summit, NJ Type: Contract Responsibilities Support Lifecycle Document Management System Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols Supervises vendors for qualification functions. Develops...

  • Field Engineering Inspector

    1 month ago

    Lee's Summit, United States City of Lee's Summit, MO Full time

    Salary: $24.12 - $36.21 Hourly Location : City Hall-Lee's Summit, MO Job Type: Full-Time Job Number: 00402 Department: Development Services Opening Date: 09/16/2024 Description The Field Engineering Inspector, under supervision of the Engineering Inspections Manager, performs technical construction inspection of work related to public and private...

  • Gas Engineer

    2 weeks ago

    Lee's Summit, Missouri, United States Spire Full time

    Job SummaryWe are seeking a highly skilled Gas Engineer to join our team at Spire. As a key member of our engineering department, you will be responsible for designing and estimating construction projects for the replacement of existing natural gas facilities and the construction of new ones.Key ResponsibilitiesDesign and estimate construction projects for...

  • Gas Engineer I

    3 weeks ago

    Lee's Summit, Missouri, United States Spire Full time

    Job SummaryWe are seeking a highly skilled Gas Engineer I to join our team at Spire. As a key member of our construction engineering group, you will be responsible for designing and estimating construction projects for the replacement of existing natural gas facilities and the construction of new natural gas facilities.Key ResponsibilitiesDesign and estimate...

  • Gas Engineer I

    2 weeks ago

    Lee's Summit, Missouri, United States Spire Full time

    Job SummaryWe are seeking a highly skilled Gas Engineer I to join our team at Spire. This role will assist the Engineering Manager and Field Operations in designing and estimating construction projects for the replacement of existing natural gas facilities and the construction of new natural gas facilities.Key ResponsibilitiesDesign and estimate construction...

  • Gas Engineer I

    2 weeks ago

    Lee's Summit, Missouri, United States Spire Energy Full time

    Job SummaryWe are seeking a highly skilled Gas Engineer I to join our team at Spire Energy. This is an exciting opportunity to work on designing and estimating construction projects for the replacement of existing natural gas facilities and construction of new natural gas facilities.Key ResponsibilitiesAssist the Engineering Manager and Field Operations in...

  • Project Manager

    2 weeks ago

    Summit, New Jersey, United States System One Full time

    Project Engineer **Job Summary** System One is seeking a skilled Project Engineer to manage projects from start to finish. The ideal candidate will have a strong background in powder processing and experience with project management software. **Responsibilities** * Manage all aspects of projects to ensure timely completion and within budget * Collaborate...

  • AI Trainer for Electrical Engineering Specialist

    2 weeks ago

    Lee's Summit, Missouri, United States Alignerr Full time

    About the RoleWe are seeking an experienced AI Trainer to join our team at Alignerr, a leading community of subject matter experts in Electrical Engineering. As an AI Trainer, you will play a crucial role in shaping the future of AI in this field.This innovative role offers a unique opportunity to leverage your subject-matter expertise and develop your AI...

  • Project Manager

    2 weeks ago

    Summit, New Jersey, United States System One Full time

    Project EngineerSystem One is seeking a skilled Project Engineer to join our team. As a key member of our engineering team, you will be responsible for managing projects from start to finish, ensuring timely and budget-friendly execution.Key Responsibilities: Review and understand project scope, including technical and commercial aspects Prepare and update...

  • Construction Site Superintendent

    1 month ago

    Summit, United States Liberty Personnel Services, Inc Full time

    Job DescriptionJob DescriptionConstruction Site Superintendent Our client in the local area is actively seeking to add a construction Site Superintendent to the organization. Construction project experience including pharmaceutical, academic, healthcare, higher education, college campus work, etc. Projects are based in the New Jersey area, typically within...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking an experienced Diesel Mechanic/Technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Key ResponsibilitiesPerform routine maintenance tasks, including oil changes, tire rotations, and brake pad...

  • Pharmaceutical Manufacturing Specialist

    4 days ago

    Summit, New Jersey, United States Omni Inclusive Full time

    The Quality Assurance Specialist for Pharmaceutical Manufacturing at Omni Inclusive plays a pivotal role in ensuring the seamless execution of validation activities and preparation of validation deliverables for the S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.This individual contributor will work closely with site...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, Mississippi, United States Penske Full time

    About the JobPenske is seeking a skilled and experienced Diesel Mechanic/Technician to join our team. As a Lead Technician, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles, as well as mentoring and leading other technicians.Main ResponsibilitiesPerforming routine maintenance and repairs on diesel engines,...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, Mississippi, United States Penske Full time

    Job SummaryPenske is seeking an experienced Diesel Mechanic/Technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Key ResponsibilitiesPerform preventative maintenance and repairs on diesel engines, transmissions, and other vehicle...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking an experienced diesel mechanic/technician to join our team. As a diesel repair specialist, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.You will work independently, performing road tests to diagnose problems and completing maintenance tasks. Our team is...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    Job OverviewPenske Truck Leasing is seeking an experienced diesel mechanic/technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Main Responsibilities:Performing routine maintenance tasks, such as oil changes and tire rotationsDiagnosing and...

  • Lead Diesel Mechanic

    3 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking an experienced Lead Diesel Mechanic/Technician to join our team. As a respected and experienced lead at your location, you will set an example and informally mentor others while learning from your manager.You will be responsible for performing preventative maintenance and repairs of all levels on the newest and...

  • Lead Diesel Mechanic

    3 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking an experienced Lead Diesel Mechanic/Technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Key ResponsibilitiesPerform routine maintenance tasks, including oil changes, tire rotations, and brake pad...

  • Lead Diesel Mechanic/Technician

    3 weeks ago

    Summit, Mississippi, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking an experienced Lead Diesel Mechanic/Technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Main Responsibilities:Maintain and repair diesel engines, transmissions, and other major componentsPerform...

  • Lead Diesel Mechanic/Technician

    2 weeks ago

    Summit, United States Penske Truck Leasing Full time

    About the JobPenske Truck Leasing is seeking a skilled Diesel Mechanic/Technician to join our team. As a key member of our maintenance team, you will be responsible for performing preventative maintenance and repairs on our fleet of vehicles.Key ResponsibilitiesMaintain and repair diesel engines, transmissions, and other componentsPerform routine maintenance...

Validation Engineer

5 months ago

Summit, United States System One Holdings, LLC Full time
Job Title: Validation Engineer

Location: Summit, NJ

Type: Contract

Responsibilities
  • Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
    • Develops qualification protocols, and associated reports while adhering to a change management process.
    • Supports the execution of equipment qualifications and validation protocols.
    • Supervises vendors for qualification functions.
    • Develops written procedures for calibration and preventive maintenance of equipment.
    • Supports equipment qualification and validation activities.
    • Develops validation/qualification deliverables such as Validation Plans, Requirements
  • Specifications, Traceability Matrices, Summary Reports, Change Controls.
  • Manages projects of limited scope and complexity within their functional area:
    • Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
    • Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
    • Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
  • Provides excellent customer service and support:
    • Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
    • Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
    • Provides technical support and guidance on equipment and computer systems qualification and validations issues.
    • Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
  • Regulatory Responsibilities
    • Ensure equipment, facilities and programs are maintained in compliance.
    • May be called upon as SME in both internal and regulatory audits.
Requirements
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Experience in the qualification of cell therapy equipment a plus
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
  • Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
  • Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Education and Experience:
  • BS in Engineering or Science related discipline required
  • Minimum of 5 years' experience performing/supporting activities in a GMP environment.
  • Minimum of 3 years' experience in equipment, facility or utility qualification


Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

#M3