Validation Engineer

3 weeks ago


Raritan, United States Cynet Systems Full time
Job Description:

Pay Range: $60hr - $65hr

Skills:

  • Computer System Validation.
  • Validating ERP to AWS Data migration process.
  • Validating Data migration project.
  • Experience in the Pharmaceutical, biotechnology, or medical device industry.
  • 5+ years experience with System Development Lifecyle.
  • 5+ years experience in Computer System Validation (Based on the role selected).
  • Experience in FDA and or Global regulated environment with good understanding of GxP standards and Risk based validation.
  • Knowledge of FDA guidance s and industry standards (i.e., GAMP).
  • Experience in writing and executing documentation for all aspects of the validation deliverables like Requirements, Compliance.
  • Validation Plans, test protocols, Test Summary reports and Compliance.
  • Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
  • Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • bility to work as a team player, lead a team or accomplish tasks without supervision.
  • bility to work with remote teams and support several changes projects simultaneously.
  • bility to provide Validation guidance, timely reviews, and escalations to Technology Quality management.

  • Validation Engineer

    12 hours ago


    Raritan, New Jersey, United States Cynet Systems Full time

    Job DescriptionCynet Systems is seeking a highly skilled Validation Engineer to join our team.Key Responsibilities:Develop and execute validation plans and protocols for CSV data solutions.Collaborate with cross-functional teams to ensure compliance with GxP standards and FDA regulations.Design and review test scripts, traceability matrices, and design...


  • Raritan, United States Piper Companies Full time

    Piper Companies is looking for an Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Raritan, NJ area.Responsibilities for the Analytical Validation Engineer include: Experience in Pharmaceutical Laboratory Operations Must be familiar and have experience with laboratory...


  • Raritan, New Jersey, United States Piper Companies Full time

    About the RolePiper Companies is seeking a highly skilled Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company.Key ResponsibilitiesPharmaceutical Laboratory Operations: The successful candidate will have experience in pharmaceutical laboratory operations, including laboratory instrument...

  • Senior CSV Engineer

    10 hours ago


    Raritan, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

    About the RoleWe are seeking a highly skilled Senior CSV Engineer to join our team at Katalyst Healthcares & Life Sciences. As a key member of our team, you will be responsible for ensuring the compliance of our manufacturing and lab systems with regulatory requirements.Key ResponsibilitiesValidation and Compliance: Perform reviews of GxP systems to ensure...

  • Senior API Engineer

    2 weeks ago


    Raritan, New Jersey, United States Georgia IT Inc Full time

    Position: Senior API Engineer Location: Raritan, NJ Duration: Contract Opportunity Compensation: Based on Experience Key Responsibilities : Architect and implement APIs that align with organizational goals and facilitate integration across diverse systems and applications. Collaborate with multidisciplinary teams to outline and execute API...


  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Position Title: Senior Manager, Infrastructure Quality AssuranceOverview:At J&J Family of Companies, we are dedicated to advancing health and well-being. We are currently seeking a Senior Manager, Infrastructure Quality Assurance to join our dynamic team.Company Mission:We believe that health is paramount. Our commitment to healthcare innovation enables us...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    Johnson & Johnson is seeking a Senior Manager, IT Quality Assurance to join our team. At Johnson & Johnson, we are committed to advancing health and well-being. Our leadership in healthcare innovation enables us to create a future where complex health challenges are addressed effectively, treatments are personalized, and solutions are more efficient. With...


  • Raritan, New Jersey, United States Wipro Full time

    Position OverviewWe are seeking a skilled Cloud Solutions Architect to join our team at Wipro. In this role, you will be responsible for the architecture, design, and development of robust data pipelines that facilitate efficient data ingestion, transformation, and processing.Key ResponsibilitiesArchitect and implement scalable data solutions that meet...

  • Process Validtion

    3 weeks ago


    Raritan, United States Novozen Healthcare LLC Full time

    Title: CQV SpecialistLocation: Raritan, NJRole Overview• This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor...

  • CSV Engineer

    3 months ago


    Raritan, NJ, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: 3+ years' Experience in Validating MES or Manufacturing an Lab systems. Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...


  • Raritan, New Jersey, United States Ortho Clinical Diagnostics Full time

    The Opportunity Ortho Clinical Diagnostics is a leader in the in vitro diagnostics sector, merging the expertise of Quidel Corporation and Ortho Clinical Diagnostics. We operate in over 130 countries, delivering precise and rapid testing solutions from home to hospital and lab to clinic. Our workplace culture emphasizes the well-being of our employees,...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    **About Johnson & Johnson**We are a global healthcare leader that puts patients at the center of everything we do. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.**Our Mission**We are committed to improving...

  • Security Analyst

    2 months ago


    Raritan, United States Brooksource Full time

    Vulnerability Management – Security Testing Raritan, NJ Long-term contract Life Sciences Industry We are seeking a Vulnerability Management – Security Testing Consultant with a Fortune Life Sciences organization located in Raritan, NJ. As a Security Consultant, you will work alongside the information security and risk management team to assess and...

  • Security Analyst

    2 months ago


    Raritan, United States Brooksource Full time

    Vulnerability Management – Security Testing Raritan, NJ Long-term contract Life Sciences Industry We are seeking a Vulnerability Management – Security Testing Consultant with a Fortune Life Sciences organization located in Raritan, NJ. As a Security Consultant, you will work alongside the information security and risk management team to assess and...


  • Raritan, New Jersey, United States Actalent Full time

    Position Title: Architect Project ManagerCompany Overview: Actalent is a renowned firm specializing in engineering and scientific services, dedicated to advancing initiatives through expert talent solutions. We are committed to fostering a diverse and inclusive environment.Role Overview: We are seeking a highly qualified Architect Project Manager to take...

  • Operations Specialist

    3 weeks ago


    Raritan, United States Legend Biotech US Full time

    Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...


  • Raritan, United States LTIMindtree Full time

    About Us:LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology expertise...


  • Raritan, United States LTIMindtree Full time

    About Us:LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology expertise...