ITSoli - LIMS Validation Engineer - ELN/Biovia

4 weeks ago


Bangalore, Karnataka, India ITSoli India Private Limited Full time

Job Title : LIMS Validation Engineer

Department : Lab Info Systems - US001

Qualification : BS in Engineering, Science or equivalent technical degree.

Work Location : Bangalore (Karnataka)

Work Mode : Hybrid (Should be ready to work from office as in when required)

Work Timing (PST hours) : 7:00 PM - 4:00 AM / 8:30 PM - 5:30 AM : Best in the Industry (Negotiable as per Industry Standards)


Job Summary :


As a LIMS Validation Engineer, you will be responsible for the validation, qualification, and compliance of the Laboratory Information Management System (LIMS). You will collaborate with cross-functional teams to ensure that the LIMS software meets regulatory standards, operational requirements, and quality standards.


Your role will involve designing and executing validation protocols, documenting validation activities, and ensuring that the LIMS functions reliably and efficiently.

Required experience :

a) 3+ years validation of Laboratory (analytical equipment / software)

b) 2+ years of work experience with any LIMS Data Analytics Software application (SoftMax Pro, GLIMS, LabX, Labware, Empower, Biovia, Discoverant, ELN, ELS).

c) Familiar with software development life cycle

d) Working knowledge of FDA and cGMP regulations and documentation practices

Job Responsibilities :

1. Writes, reviews and revises a variety of installation, operation and performance qualification/verification related documents, including any of all of the following : SOPs, validation/verification master plans, guidelines and execution plans, qualification or other technical documents, user requirement specifications (URS), Design specifications (DS), functional requirement specifications (FRS) and verification protocols

2. Provide assistance in drafting the validation protocols (IQ, OQ, PQ) for systems and processes for qualification/ verification and/ or re-qualification/ re-verification.

3. Writes and executes protocols, assist in drafting the deviations/discrepancies and draft summary reports.

4. Writes reports to summarize Validation/verification and/or re-validation/verification activities.

5. Responsible for drafting change control documents.

Key Requirements :

1. 3+ year experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

2. Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation protocols (IQ, OQ, PQ, PV, CV, CSV, etc), Quality Systems (Change Control, Non-conformances, Re-qualification, etc) and Process Excellent Methodologies (Six Sigma, Lean, etc).

3. Excellent written and verbal communication skills; excellent technical writing skills.

4. Strong interpersonal skills and the ability to work in a team environment.

5. Ability to work effectively in a fast-paced multitasking environment.

6. Strong working knowledge of FDA and cGMP regulations and documentation practices.

7. Proficient in Microsoft Word, Excel, PowerPoint.

8. Working for multiple clients throughout the region.

(ref:hirist.tech)

  • Bangalore/Hyderabad, Karnataka, India ITSOLI India Private Limited Full time

    Job Title : Discoverant DeveloperDepartment : Lab Info Systems - US001Qualification : Bachelor's degree in computer science, Software Engineering, or related field.Work Location(s) : Bangalore (Karnataka) / Hyderabad (Telangana)Work Mode : Hybrid (Should be ready to work from office as in when required)Work Timing (PST hours) : 7:00 PM - 4:00 AM / 8:30...


  • Bangalore, Karnataka, India TD Newton Full time

    Your key responsibilities :Technical Excellence :- Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)- Create/review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ,...


  • Bangalore, Karnataka, India ITSOLI India Private Limited Full time

    Job Title : Infrastructure Delivery Manager - Enterprise Service ManagementQualification : Bachelor degree in Computer Science, Software Engineering, or related field.Work Location : Bangalore (Karnataka)Work Mode : Hybrid (Should be ready to work from office as in when required)Work Timing (PST hours) : 7:00 PM - 4:00 AM / 8:30 PM - 5:30 AM (IST)Salary :...


  • Bangalore, Karnataka, India ITSoli India Private Limited Full time

    Designation : VMware and Cloud EngineerQualification : Bachelor's degree in computer science, Information Technology, or related field.Experience : Minimum 5+ years of relevant working experience in VMware technologies (e.g., vCenter, ESXi, vSphere, etc.) along with proficiency in Linux operating systems. Experience with Nutanix is highly desirable. The...


  • Bangalore, Karnataka, India ITSoli India Private Limited Full time

    Job Title : Data Modeler (Supply Chain Management)Qualification : Bachelor's degree in computer science, Information Systems, or related field.Work Location : Indiranagar, Bangalore (Karnataka)Work Mode : Hybrid (Should be ready to work from office as in when required)Salary : Best in the Industry (Negotiable as per Industry Standards)Job Summary : As a...

  • Senior Staff Engineer

    1 month ago


    Bangalore, Karnataka, India ETEROS TECHNOLOGIES PRIVATE LIMITED Full time

    Role Description :This is a full-time on-site role for a CAN/LIN Sr Staff EE Validation Engineer located in Bengaluru. As a CAN/LIN Sr Staff EE Validation Engineer, you will be responsible for the day-to-day tasks associated with electrical and electronic system validation. You will collaborate with cross-functional teams to ensure product compliance with...

  • Application Engineer

    1 month ago


    Bangalore, Karnataka, India MY Search Full time

    Our MNC client is a fabless semiconductor company providing high performance IC products in IoT Radios, Timing and Audio Markets.They are looking for Application Engineer (Analog Validation / 3 to 8 years) to be based at Bangalore with the following : - Total 3 to 8 years in developing Analog Validation, Bench Validation and Characterization Plans, hardware...


  • Bangalore, Karnataka, India MY Search Full time

    Our MNC client is a leading semiconductor company designing IC products in High-Performance Timing (Clocking), RF and Power Management area.They are looking for Senior Analog Validation to be based at Bangalore with the following : - Total 7 to 11 years in developing Analog Validation, Bench Validation and Characterization Plans, hardware and software.-...


  • Bangalore, Karnataka, India Havells India Limited Full time

    Job Description :Educational Qualifications : B.E./B.Tech./M.Tech. in electronic/electrical engineering with 4 -10 years of work experience in System Validation, Testing & Debugging & Python ,C Programming System Validation Engineer - 5 -12 years industry experience in embedded systems, IoT, and connected product efforts. - Hands on exposure in any of these...


  • Bangalore, Karnataka, India Excellence and Eminence LLP Full time

    About the Role :We are seeking a highly motivated and experienced Embedded Software Validation Engineer to join our team and play a crucial role in ensuring the quality and safety of our client's embedded systems. This role is ideal for a candidate with a strong understanding of verification and validation processes, particularly for safety-critical...


  • Bangalore, Karnataka, India MY Search Full time

    Our MNC client is a leading semiconductor company designing IC products in High-Performance Timing (Clocking), RF and Power Management area.They are looking for Analog Validation to be based at Bangalore with the following : - Total 3 to 7 years in developing Analog Validation, Bench Validation and Characterization Plans, hardware and software.- Ensuring the...


  • Bangalore, Karnataka, India MY Search Full time

    Our MNC semiconductor client provides high performance IC products in IoT Radios, Timing and Audio Markets.They are looking for Post Silicon Validation Engineer to be based at Bangalore with the following: - Total 1 to 10 years of experience in developing Analog Validation, Bench Validation and Characterization Plans, hardware and software.- Ensuring the...


  • Bangalore, Karnataka, India MY Search Full time

    Applications Engineer (RF Group or Timing Group)About the Client : Our MNC semiconductor client provides high-performance IC products in IoT Radios, Timing and Audio Markets.They are looking for Application Engineer to be based at Bangalore with the following : - The ideal candidate will have 3 to 7 years of experience with 3+ years of experience...


  • Bangalore, Karnataka, India HeadPro Consulting LLP Full time

    Position Responsibilities :Compile relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems.Support, and iterate models in Manufacturing Execution System (MES) used for testing enhancements in MES for backward...


  • Bangalore, Karnataka, India MY Search Full time

    Job Description :Our client is a technology consulting company with focus on Semiconductor ASIC Design Services, Embedded Software Development bringing best-in-class expertise - from specification to design and development with first pass silicon success.They are looking for Senior FPGA or Emulation Validation Engineers to be based at Bangalore with the...


  • Bangalore, Karnataka, India MY Search Full time

    Our MNC client is a leading semiconductor company designing IC products in High Performance Timing (Clocking), RF and Power Management area.They are looking for Analog Validation to be based at Bangalore with the following: - Total 3 to 7 years in developing Analog Validation, Bench Validation and Characterization Plans, hardware and software.- Ensuring the...


  • Bangalore, Karnataka, India Indium Software Full time

    Job Description :You will combine your software testing expertise with your understanding of machine learning to design and execute comprehensive test plans that identify and mitigate issues before models are deployed to production.Responsibilities :Machine Learning Expertise :- Translate business problems into machine learning problems.- Understand and...


  • Bangalore, Karnataka, India Chadwick Professional Services Private Limited Full time

    Responsibilities :- Design, develop, and execute comprehensive test plans for embedded software systems.- Utilize automation frameworks and tools to create and maintain automated test scripts (4+ years of experience required).- Perform manual testing to complement automated testing efforts.- Conduct API testing to ensure proper functionality and...


  • Bangalore, Karnataka, India Onward Technologies Limited Full time

    Position Summary : Key Responsibilities :Reviewing software requirements (SWE 1) and ensuring their completeness and accuracy.- Developing and executing software qualification tests (SWE 6) to verify compliance with specifications.- Utilizing AUTOSAR software for automotive applications.- Proficient in Python, CAPL programming, or other automation scripting...


  • Bangalore, Karnataka, India Sourceone Staffing & Consulting Pvt Ltd Full time

    API & Integration Testing EngineerLocation : BengaluruExp : 5 to 8 yearsSkills : 1. Candidate must have experience in conducting end-to-end /Integration Testing ensuring data accuracy, completeness, and integrity throughout the data flows and write test scripts to validate different data workflows, data transformations, data structure and data mappings.2....