Senior Computer System Validation Specialist

3 weeks ago

South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

We are seeking a highly skilled Senior Computer System Validation Specialist to join our team at Katalyst HealthCares & Life Sciences. As a key member of our IT Computerized System Validation (CSV) Department, you will be responsible for leading and directing GxP computerized system validation projects in compliance with cGMP, CFR Part and Annex.

Key Responsibilities

  • Provide independent technical leadership and accountability for overall computer system validation efforts.
  • Ensure quality and compliance in accordance with established procedures and standards of the Quality Systems by applying critical thinking to CSV work.
  • Generate, review, and approve base level documents such as Validation Plan, URS, FRS, DS, and SOPs in support of Computerized System Validation/Assurance activities.
  • Develop, implement, and maintain computer system validation-related controlled documents to support the initiation, validation, operation, and maintenance of GxP systems.
  • Assist with change controls, CAPAs, deviations, and exceptions required as part of system validation efforts.
  • Support system administrative & maintenance activities for Lab Systems.
  • Support continuous improvement efforts by monitoring, tracking and performing the steady state activities for Lab Systems.
  • Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part and Annex.
  • Collaborate/lead/participate in decision-making and make recommendations regarding the best options for validation of computer systems. Maintain close communication with stakeholders and team members to keep apprised of computer system needs, impact on computer system validation, project validation status, and other relevant issues.
  • Collaborate with Revance-approved vendor personnel in coordinating validation efforts including reviews/approvals of related validation deliverables and for ensuring a successful validation lifecycle.
  • Reviews department-specific SOPs periodically and updates if/as needed to ensure that the procedures are always up to date based on the latest regulatory updates and industry best practices.
  • Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
  • Facilitate the computer system validation risk assessments System level, Requirement level risk assessments, & System and Data Audit Trail assessments, etc.
  • Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems.
  • Perform Periodic System Reviews ensuring that the systems maintain their validated status.
  • Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV

Requirements

  • Minimum Required: Bachelor's degree in Engineering, Science, or a related technological field
  • Minimum Required: Minimum of Six (-) years or more in the pharmaceutical industry with GMP experience.
  • Understanding phases of Life Cycle Validation approach and practical working knowledge of computer system validation/computer software assurance requirements.
  • Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP, CFR Part and Part, EudraLex Volume and Annex, and ICH Q, Q, Q and Q.
  • Demonstrate ability to effectively manage multiple projects/priorities
  • Demonstrate excellent written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Must work effectively within teams with rapidly changing priorities.
  • Demonstrates analytical problem-solving skills.

  • Senior Validation Engineer

    4 weeks ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Job Summary: We are seeking a highly skilled Senior Validation Engineer to join our team at Katalyst HealthCares & Life Sciences. As a key member of our team, you will be responsible for ensuring the integrity of our data and systems, while maintaining compliance with regulatory requirements. Responsibilities: Perform data integrity risk assessments and...

  • Senior Software Development Specialist

    3 weeks ago

    South Plainfield, New Jersey, United States Rigas Technologies Inc. Full time

    Job Title: Senior Software Development SpecialistAbout the Role:We are seeking a highly skilled Senior Software Development Specialist to join our team at Rigas Technologies Inc. The ideal candidate will have a strong background in software development, with experience in designing, developing, testing, customizing, and implementing software module...

  • Validation Specialist

    3 weeks ago

    Plainfield, New Jersey, United States United Pharma Technologies Inc Full time

    Job Summary:As a Validation Specialist at United Pharma Technologies Inc, you will be responsible for managing specification, qualification, and validation requirements. This includes writing and executing engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, and...

  • Senior Quality Assurance Specialist

    4 weeks ago

    South Plainfield, New Jersey, United States Astir Technologies Full time

    Job SummaryAs a Senior Quality Assurance Specialist at Astir Technologies, you will be responsible for analyzing, reviewing, and translating business and test requirements into functional specifications. You will ensure the validation of deliverables, design, develop, and maintain functional test cases, and execute and evaluate manual or automated test...

  • Senior Software Development Professional

    3 weeks ago

    South Plainfield, New Jersey, United States Binary Computer Int'l Corp Full time

    Job Summary: We are seeking a highly skilled Sr. Software Engineer to design, develop, test, enhance, customize, and coordinate activities to implement advanced software module components in complex computing environments using the latest tools and technologies on different operating systems.Key Responsibilities:Design and develop software module...

  • Electrical Systems Design Specialist

    3 weeks ago

    South Plainfield, New Jersey, United States Liberty Personnel Services, Inc Full time

    At Liberty Personnel Services, Inc., we are seeking a skilled Electrical Systems Design Specialist to join our team. This is an exceptional opportunity to advance your career and work on a variety of residential, commercial, and institutional projects.Job SummaryAs an Electrical Systems Design Specialist, you will be responsible for designing and coding...

  • Security Systems Installation Specialist

    4 weeks ago

    South Plainfield, New Jersey, United States Azend Pharma Full time

    Job OverviewWe are seeking a skilled Installation and Repair Specialist to join our team. As a Security Systems Installation Specialist, you will travel to various locations and job sites to accurately install or repair security systems based on customer specifications and location restrictions.Key ResponsibilitiesTravel to various locations and assess...

  • Senior File Transfer Specialist

    3 weeks ago

    Plainfield, New Jersey, United States Saxon Global Full time

    Job Title: Senior File Transfer SpecialistWe are seeking a highly skilled Senior File Transfer Specialist to join our team at Saxon Global. As a key member of our Integration Platform Engineering team, you will be responsible for developing and maintaining software and systems to integrate internal and cloud systems.Key Responsibilities:* Develop and...

  • Senior Mechanical Systems Engineer

    4 weeks ago

    Plainfield, New Jersey, United States Public Service Enterprise Group Inc Full time

    Job SummaryAs a Senior Mechanical Systems Engineer, you will provide technical support in the Engineering Services department for the Salem Power Uprate Project. The successful candidate will perform the duties as a System/Commissioning Engineer for the power uprate for Salem Units 1 and 2.Key ResponsibilitiesAssess the required scope of work and explore...

  • Fire Sprinkler System Specialist

    3 weeks ago

    South Plainfield, New Jersey, United States Approved Fire Protection Co Inc. Full time

    Job OverviewApproved Fire Protection Co. Inc. is seeking a skilled Fire Sprinkler System Specialist to join our team. As a key member of our team, you will be responsible for installing, repairing, and maintaining wet/dry/pre-action sprinkler systems.Key Responsibilities:Perform installations, repairs, and testing of sprinkler systems.Follow safety...

  • Senior Application Engineer Lead

    3 weeks ago

    South Plainfield, New Jersey, United States Lotus Technology Group, Inc. Full time

    Job Title: Technical Lead - Application EngineerJob Summary: We are seeking a highly experienced Technical Lead to join our team at Lotus Technology Group, Inc. as an Application Engineer. The successful candidate will have a strong background in aligning IT systems with organizational business processes and lead capacity experience.Key Responsibilities: ...

  • Senior Software Development Expert

    4 weeks ago

    South Plainfield, New Jersey, United States P3 GEEKS INC Full time

    Job Summary:As a Senior Software Development Expert at P3 Geeks Inc., you will design, develop, and test software applications and utility programs on various operating systems using the latest tools and technologies in a complex computing environment. This role requires a Master's degree in Computer Science, Engineering, Information Technology, or...

  • Senior Application Engineer Lead

    4 weeks ago

    South Plainfield, New Jersey, United States Lotus Technology Group, Inc. Full time

    Job Title: Technical Lead (Application Engineer)Select employment type: Long Term ContractLocations: RemoteJob Description:Key Requirements: 5+ years of experience in aligning IT systems with organizational business processes.Leadership Experience: 3+ years of experience in a lead capacity, driving teams to achieve business objectives.Education and...

  • Senior Controls Systems Engineer

    4 weeks ago

    South Plainfield, New Jersey, United States Public Service Enterprise Group Inc Full time

    Job SummaryProvide technical support in the Engineering Services department for the Salem Power Uprate Project. The successful candidate will perform the duties as a System/Commissioning Engineer for the power uprate for Salem Units 1 and 2. The engineer is responsible for sponsoring and implementing power uprate modifications.Key ResponsibilitiesAssess the...

  • Diesel Technician Position

    2 weeks ago

    South Plainfield, New Jersey, United States Ryder System Full time

    Ryder System Diesel Mechanic Job DescriptionWe are seeking a skilled Diesel Technician to join our team at Ryder System in South Plainfield, NJ. As a Diesel Mechanic, you will be responsible for performing basic vehicle maintenance, component identification, and minor repairs. Key Responsibilities:Performs basic vehicle maintenancePerforms component...

  • Senior Mechanical Systems Commissioning Specialist

    3 weeks ago

    Plainfield, New Jersey, United States Public Service Enterprise Group Inc Full time

    Job SummaryPublic Service Enterprise Group Inc is seeking a skilled Commissioning Engineer for Mechanical Systems to join our team in the Engineering Services department. The successful candidate will provide technical support for the Salem Power Uprate Project, specifically for the power uprate for Salem Units 1 and 2.Key ResponsibilitiesAssess the required...

  • Documents Systems Specialist

    3 weeks ago

    Plainfield, New Jersey, United States MILLENNIUMSOFT Full time

    Job SummaryAs a Documents Systems Specialist at MillenniumSoft, you will be responsible for working cross-functionally in the development, review, and revision of documents for Supply Chain processes. This includes but is not limited to distribution center Quality and Operations.Key ResponsibilitiesParticipate in the development, review, improvement, and...

  • Senior Mechanical Systems Engineer

    4 weeks ago

    Plainfield, New Jersey, United States Public Service Enterprise Group Inc Full time

    Job SummaryAs a Senior Mechanical Systems Engineer at Public Service Enterprise Group Inc, you will provide technical expertise in identifying, investigating, and resolving plant operating, safety, and design issues to ensure plant reliability and availability.Key ResponsibilitiesMonitor and assess systems and components to improve reliabilityEstablish...

  • Lead Mechanical Systems Commissioning Specialist

    4 weeks ago

    South Plainfield, New Jersey, United States Public Service Enterprise Group Inc Full time

    Job SummaryAs a System/Commissioning Engineer for the Salem Power Uprate Project, you will provide technical support in the Engineering Services department. The successful candidate will perform duties such as sponsoring and implementing power uprate modifications, ensuring adequate systems integration, and fulfilling the role of plant systems subject matter...

  • Manufacturing Systems Specialist

    4 weeks ago

    South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time

    Job Summary:We are seeking a highly skilled Manufacturing Systems Consultant to join our team at Katalyst HealthCares & Life Sciences. The ideal candidate will have experience in conducting comprehensive gap analyses and developing system roadmaps for CAR-T manufacturing.Key Responsibilities:• Conduct thorough gap analysis of existing systems to identify...