Validation Engineer

2 weeks ago


Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

CQV Engineer

Location: Boston/Rhode Island

Key Responsibilities:

  • Develop and execute Quality System documentation aimed at promoting effective validation practices within the organization.
  • Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring adherence to Good Documentation Practices (GDP) and internal quality benchmarks.
  • Formulate validation strategies, backed by suitable statistical analyses, oversee all validation tasks, evaluate and compile results, and prepare comprehensive validation reports.
  • Contribute insights on user and functional requirements for current and upcoming processing equipment, and generate relevant documentation. Collaborate with Contract Manufacturers to ensure all necessary user and functional requirements are fulfilled.
  • Assist non-engineering personnel, including R&D and Manufacturing teams, to facilitate successful technology transfer and ongoing improvements.
  • Carry out assigned responsibilities punctually and proactively communicate any delays or issues to the validation manager and other pertinent stakeholders.
  • Adhere to all regulatory, corporate, and Quality System protocols.

Required Qualifications:

  • Bachelor's or Master's degree in engineering or a related field.
  • A minimum of 5 years of experience in a medical device setting or other FDA-regulated environments, with experience in device-biologic combination products being highly advantageous.
  • Proficiency in Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.).
  • Solid understanding of the Computer Systems Validation lifecycle and associated documentation.
  • Skilled in Microsoft Word, Excel, and PowerPoint.
  • Able to work independently with minimal supervision, manage multiple tasks, and support various projects concurrently.
  • Exhibit strong communication, interpersonal, and teamwork capabilities.
  • A robust understanding of technical writing and presentation skills is essential.

  • Validation Engineer

    1 week ago


    Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

    CQV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and implement documentation for Quality Systems aimed at promoting effective validation practices within the organization.Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring...

  • Validation Engineer

    1 week ago


    Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

    CQV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and implement documentation for Quality Systems aimed at promoting effective validation practices within the organization.Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring...

  • Validation Engineer

    1 week ago


    Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

    CQV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and implement documentation for Quality Systems aimed at promoting effective validation practices within the organization.Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring...

  • Validation Engineer

    1 week ago


    Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

    CQV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and implement documentation for Quality Systems aimed at promoting effective validation practices within the organization.Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring...

  • Validation Engineer

    2 weeks ago


    Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

    CQV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and execute Quality System documentation aimed at promoting effective validation practices within the organization.Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring...


  • Providence, Rhode Island, United States CAI Full time

    Position Overview: The CQV Specialist is responsible for creating documentation related to the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. This role involves writing and executing protocols (field verification) and developing comprehensive summary reports at client locations. Additional...


  • Providence, Rhode Island, United States SAIC Full time

    Job SummaryWe are seeking a highly experienced and skilled Chief Engineer of Undersea Systems to join our team at SAIC. As a senior technical leader, you will be responsible for the execution of current programs and the design of future weapons and test sets.Key ResponsibilitiesServe as a senior adviser to the Vice President for Undersea Warfare and Support,...


  • Providence, Rhode Island, United States Stantec Full time

    Position OverviewStantec is seeking a highly experienced Senior Structural Engineer specializing in waterfront and marine infrastructure. This role is integral to our New England Transportation operations, focusing on the design and execution of large-scale waterfront projects.Key ResponsibilitiesConduct comprehensive engineering assignments related to...


  • Providence, Rhode Island, United States Cisco Full time

    About the RoleCisco is seeking a highly skilled and experienced Principal Engineer to lead our Product Security team. As a key member of our engineering organization, you will be responsible for designing, building, and deploying secure software systems that meet the highest standards of quality and reliability.Key ResponsibilitiesLead by example and...


  • Providence, Rhode Island, United States Michael Page Full time

    About the RoleWe are seeking a highly skilled Senior Mechanical Engineer to lead our mechanical design efforts in advanced manufacturing solutions. As a key member of our team, you will be responsible for conceptualizing, designing, and validating mechanical systems and components.Key ResponsibilitiesLead Mechanical Design Efforts: Develop and implement...


  • Providence, Rhode Island, United States Acceler8 Talent Full time

    System Test EngineerAcceler8 Talent is seeking a skilled System Test Engineer to contribute to a pioneering startup focused on high-speed, high-density, and low-power optical transceivers designed for AI, machine learning, and data center communications.As a vital member of the team, you will engage with leading experts in the opto-electronic field,...


  • Providence, Rhode Island, United States Michael Page Full time

    Opportunity OverviewThis is a chance to engage with state-of-the-art technology within a dynamic organization that values innovation and production efficiency.About the CompanyOur client stands at the forefront of advanced manufacturing solutions, specializing in sectors such as semiconductor fabrication and nanotechnology.Role ResponsibilitiesAs a Senior...


  • Providence, Rhode Island, United States Michael Page Full time

    About the OpportunityThis position offers a chance to engage with state-of-the-art technology within a dynamic organization that values innovation and growth in production capabilities.Company OverviewOur client is a prominent provider of sophisticated manufacturing solutions in the advanced technology sector. We focus on pioneering technologies that enhance...


  • Providence, Rhode Island, United States Michael Page Full time

    Opportunity OverviewJoin a dynamic organization at the forefront of technological advancement in manufacturing. Our client is recognized as a premier provider of innovative manufacturing solutions across various industries. About the CompanyOur client excels in pioneering technologies that enhance efficiency and drive progress in sectors such as...


  • Providence, Rhode Island, United States Michael Page Full time

    About the RoleThis position offers a chance to engage with state-of-the-art technology and be part of a dynamic organization that values contributions to production processes.Company OverviewOur client is a prominent provider of sophisticated manufacturing solutions within the advanced technology sector. We focus on pioneering innovations that enhance...


  • Providence, Rhode Island, United States Michael Page Full time

    Opportunity OverviewJoin a forward-thinking organization that leverages state-of-the-art technology to enhance production capabilities. Our client is a prominent player in the field of advanced manufacturing solutions. About the CompanyOur client excels in pioneering technologies that foster innovation and efficiency across diverse sectors, including...


  • Providence, Rhode Island, United States Michael Baker International Full time

    About Michael Baker InternationalMichael Baker International is a leading provider of innovative solutions to transportation challenges. Our team of experts has a proven track record of delivering high-quality projects that meet the needs of our clients and communities.Job SummaryWe are seeking a highly skilled Staff Engineer/Bridge Inspector to join our...


  • Providence, Rhode Island, United States Acceler8 Talent Full time

    Optical Communication Systems Test EngineerAcceler8 Talent is seeking a skilled Optical Communication Systems Test Engineer to contribute to the development of innovative high-speed optical transceivers tailored for AI and datacenter communications. This role involves working with a dynamic team in a rapidly growing environment focused on cutting-edge...


  • Providence, Rhode Island, United States Cisco Full time

    About the RoleCisco is seeking a highly skilled and experienced Principal Engineer to join our Product Security team. As a key member of our engineering team, you will be responsible for leading by example and architecting systems alongside and with teams, enhancing and adopting new authentication and authorization mechanisms.Key ResponsibilitiesLead by...


  • Providence, Rhode Island, United States Acceler8 Talent Full time

    Position: System Test EngineerAcceler8 Talent is seeking a highly skilled System Test Engineer to contribute to the development of innovative optical transceivers designed for artificial intelligence, machine learning, and data center communications. This role is pivotal in a rapidly expanding startup that is at the forefront of optical technology.Key...