Validation Engineer

1 month ago


Danvers, United States HCLTech Full time

About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website -


Job Description:


  • As a Test Method Validation Engineer (m/f/d), you will carry out tests according to standardized guidelines (FDA, SOPs, Work Instruction)
  • Lead process validation efforts, ensuring that manufacturing processes are validated according to SOP’s and industry best practices.
  • You will be responsible for the design and execution of tests to verify the requirements and specifications of products. This includes data analysis of historical test data.
  • You will be responsible for the design and creation of test plans and protocols as well as test reports.
  • You are responsible for the planning and implementation of test method validations.
  • You are responsible for authorizing validation protocol and reports.
  • Involve vendor interactions and travel to finalize the validation requirements.


Qualification :


  • Bachelor's or Master's degree in natural sciences or engineering with a technical focus or technician with laboratory experience


Experience:


  • Years of practical experience in the field of test method validation in a laboratory environment
  • You have knowledge of the medical device verification and validation (5 years)
  • Familiarity with electrical/mechanical systems as well as experience in conducting tests.
  • Experience in working with statistical analysis and application software (e.g. Minitab)
  • Experience in documentation as well as with GLP, GDP and QMS
  • Experience statistical tools and methodologies for process optimization and control (IQ, OQ, PQ, PPQ, TMV, Gauge RR, Cpk, SPC).
  • Excellent communication, interpersonal, and problem-solving skills.



  • Danvers, Massachusetts, United States The Chemical Engineer Full time

    About the RoleWe are seeking a highly skilled Senior Process Engineer II to join our team at The Chemical Engineer. As a key member of our engineering team, you will be responsible for leading early-stage design and process development projects for novel hemodynamic support devices and accessories.Key ResponsibilitiesLead initiatives with engineers in...


  • Danvers, United States Johnson & Johnson Full time

    Description Abiomed, Inc. (a member of Johnson & Johnson Family of Companies), is currently seeking a Senior Test Engineer I to join our extraordinary team located in Danvers, MA! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,...


  • Danvers, Massachusetts, United States HCLTech Full time

    About HCLTech: HCLTech is a leading global technology organization, employing over 223,400 professionals across 60 countries. We specialize in delivering exceptional capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaborations span...


  • Danvers, Massachusetts, United States HCLTech Full time

    About HCLTech: HCLTech is a leading global technology organization, employing over 223,400 professionals across 60 countries. We provide top-tier capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaboration spans various industries,...


  • Danvers, United States Merck KGaA Full time

    Work Location:Danvers, Massachusetts Shift: Department:LS-SC-WSAB US Danvers Mobius Product Eng Recruiter: Carolyn Angle Jones This information is for internals only. Please do not share outside of the organization. Your Role: The Senior Plastics Engineer is a key resource within the Product Engineering Team in the support of Mobius Single Use products that...

  • Test Engineer III

    1 month ago


    Danvers, United States Mondo Full time

    Title: Test Engineer IIILocation: Onsite in Danvers, MADuration: 12+ months with opportunity for hire after 6; includes benefitsStart Date: ASAPRate: Competitive and dependent upon experienceUnfortunately, we cannot work with third party employers or those on STEM visas at this time.As a Test Engineer, you will drive technical efforts, support design...

  • Test Engineer III

    1 month ago


    Danvers, United States Mondo Full time

    Title: Test Engineer IIILocation: Onsite in Danvers, MADuration: 12+ months with opportunity for hire after 6; includes benefitsStart Date: ASAPRate: Competitive and dependent upon experienceUnfortunately, we cannot work with third party employers or those on STEM visas at this time.As a Test Engineer, you will drive technical efforts, support design...


  • Danvers, Massachusetts, United States Jobot Full time

    Job Title: Marine MechanicCompany: JobotJob Overview:We are looking for a skilled marine mechanic to assess, communicate, and resolve issues related to various types of marine engines and systems. The successful candidate will possess:Proficiency in working with mechanical systems and enginesA valid driver's licenseExperience in the marine sector (preferred...

  • CNC Sales Engineer

    2 days ago


    Danvers, Massachusetts, United States The Robert E. Morris Full time

    Job SummaryWe are seeking a highly skilled Sales Engineer to join our team at The Robert E. Morris Company. As a Sales Engineer, you will play a critical role in supporting our Capital Equipment sales process by providing technical information and expertise to improve the productivity of our customers.Key ResponsibilitiesDevelop and maintain strong...

  • Full Stack Engineer

    2 months ago


    Danvers, United States forREAL Full time

    Be part of the founding engineering team at a real-estate tech startup out of MIT that is going to disrupt the long-term rental market. We are modernizing the process of validating, browsing, visiting, and renting apartments - starting in Boston. This is a full-time, on-site, role at our office in downtown Danvers, MA.As part of the founding engineer team,...

  • Full Stack Engineer

    2 months ago


    Danvers, United States forREAL Full time

    Be part of the founding engineering team at a real-estate tech startup out of MIT that is going to disrupt the long-term rental market. We are modernizing the process of validating, browsing, visiting, and renting apartments - starting in Boston. This is a full-time, on-site, role at our office in downtown Danvers, MA.As part of the founding engineer team,...


  • Danvers, Massachusetts, United States Neurologica Full time

    About the RoleWe are seeking a highly skilled Electrical Design Engineer to join our team at NeuroLogica Corporation. As a key member of our engineering team, you will be responsible for designing and developing electrical systems for our CT data acquisition systems.Key ResponsibilitiesDesign and develop electrical systems for CT data acquisition systems,...

  • Senior Test Engineer

    1 month ago


    Danvers, United States Mondo Full time

    Overview:We are seeking a highly skilled Senior Test Engineer to join our team. This role will focus on end client integrations, ensuring that our testing processes align with their specific rules and regulations. The ideal candidate will spend a significant amount of time in the lab, writing web instructions for different equipment and validating test...

  • Senior Test Engineer

    1 month ago


    Danvers, United States Mondo Full time

    Overview:We are seeking a highly skilled Senior Test Engineer to join our team. This role will focus on end client integrations, ensuring that our testing processes align with their specific rules and regulations. The ideal candidate will spend a significant amount of time in the lab, writing web instructions for different equipment and validating test...


  • Danvers, Massachusetts, United States Merck KGaA Full time

    About the RoleThe Senior Plastics Engineer will play a key role in the Product Engineering Team, supporting the development of Mobius Single Use products across our global network of manufacturing sites. This is a unique opportunity for a collaborative and innovative individual to join our team and contribute to the growth of our rapidly expanding product...

  • Electrical Engineer

    2 days ago


    Danvers, Massachusetts, United States Neurologica Full time

    About the RoleWe are seeking an experienced Electrical Design Engineer to join our team at NeuroLogica Corporation. As a key member of our engineering team, you will be responsible for designing and developing electrical systems for our CT data acquisition systems.Key ResponsibilitiesDesign and develop electrical systems for CT data acquisition systems,...


  • Danvers, Massachusetts, United States Johnson and Johnson Full time

    At Johnson & Johnson, we hold the belief that health is paramount. Our prowess in healthcare innovation enables us to create a world where intricate diseases are prevented, treated, and cured, where therapies are more intelligent and less invasive, and where solutions are tailored to individual needs. Through our expertise in Innovative Medicine and MedTech,...

  • Quality Engineer

    21 hours ago


    Danvers, United States Intellectt Inc Full time

    Role: Quality EngineerLocation: Danvers, MADuration: 12+ Months Shift Timings: 3rd Shift 10pm-6:30amMAIN RESPONSIBILITIES • Responsible for performing line clearance, shift change activities, set up verification and label verification. • Independently contribute to Quality System processes which may include training, corrective action and preventive...


  • Danvers, United States Neurologica Full time

    DAS/CT Electrical Engineer WHO WE ARE: NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed...

  • Engineer

    1 month ago


    Danvers, United States Candlewood Boston-Danvers Full time

    Job Summary: Informacin disponible en espaol a continuacin. The Maintenance Engineer is responsible for assisting with the operation maintenance service and repair of equipment as assigned. He/she is also responsible for participating in the preventative maintenance program handling guest requests and other work orders as assigned. He/she is also responsible...