Validation Analyst Engineer

2 days ago

Chennai, Tamil Nadu, India ti Steps Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Summary:

The Validation Analyst/Engineer is responsible for assisting in the planning, execution, and documentation of validation activities and Change Management process. This role involves reviewing change requests, collaborating with cross-functional stakeholders, and ensuring changes are processed according to established procedures and regulatory guidelines. The ideal candidate will have a foundational understanding of validation principles, quality systems, and a desire to develop expertise in a regulated environment.

Key Responsibilities:

Change Management Support:

  • Review Change Requests (CRs) to assess the impact on validated systems, equipment, or processes.
  • Collaborate with initiators, system owners, Quality Assurance (QA), and other subject matter experts (SMEs) to define appropriate validation and testing strategies for proposed changes.
  • Ensure all necessary documentation (e.g., risk assessments, impact analysis, d) is accurately prepared and complete prior to change implementation.
  • Process change records through the workflow, ensuring timely execution of tasks and compliance with standard operating procedures (SOPs).
  • Maintain and archive change control documentation in the designated Quality Management System (QMS).

Validation Documentation and Execution:

  • Assist in the creation, revision, and execution of validation documents, including:
  • Validation Plans (VPs)
  • Qualification Plan
  • Review Test Scripts and Traceability Matrices
  • Validation Summary Reports (VSRs)
  • Support the execution of testing activities, ensuring adherence to approved processes and Good Documentation Practices (GDP).
  • Document and investigate any deviations or non-conformances identified during testing and assist in defining corrective and preventive actions (CAPAs).

Compliance and Quality:

  • Perform Periodic Access Reviews working with Product Owners
  • Stay current with relevant industry regulations (e.g., FDA, EMA, GxP, 21 CFR Part 11).
  • Ensure all validation activities and documentation meet internal company policies and regulatory requirements.
  • Provide support during internal and external audits/inspections related to validation and change control documentation.

Qualifications

Education:

  • Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biomedical Engineering, Computer Science, Chemistry, or a related field).

Experience:

  • 3-4 years of experience in a regulated industry (e.g., Pharmaceutical, Biotechnology, Medical Device).

Skills and Competencies

  • Good understanding of validation lifecycle (e.g., system development life cycle, GxP concepts).
  • Understanding of Change Control principles and processes.
  • Good written and verbal communication skills for collaborating with diverse stakeholders.
  • Strong attention to detail and organizational skills to manage documentation effectively.
  • Ability to work both independently and as part of a team.
  • Proficiency with Google Suite (sheets, Docs etc) or Microsoft Office Suite (Word, Excel, PowerPoint).

  • Validation Testing Engineer

    2 weeks ago

    Chennai, Tamil Nadu, India Reveille Technologies,Inc Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Hiring: Validation Testing Engineer FTE Experience: 4–10 Years (Minimum 4+ Years Relevant) Notice Period: Immediate Joiners Preferred Location: chennaiKey Skills (Mandatory): Validation Testing with SQLGood to Have: Automation Testing DM or share your ./.

  • Senior Validation Engineer

    1 week ago

    Chennai, Tamil Nadu, India ValGenesis Full time US$ 90,000 - US$ 1,20,000 per year

    About ValGenesisValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.Learn more about working...

  • HIL Validation Engineer

    1 day ago

    Chennai, Tamil Nadu, India Themesoft Inc. Full time ₹ 12,00,000 - ₹ 15,00,000 per year

    Greetings from ThemesoftWe are seekingHIL Validation Engineerswho are passionate about automotive systems, testing, and automation to join our client inChennai location.Location:ChennaiExperience:6+ years to 10 yearsNotice Period:Immediate joinersPosition:ContractDomain:Automotive Electronics / Electrical SystemsSkills Required:dSPACE, ECU Test Tool, EOL...

  • Hil Validation Engineer

    3 days ago

    Chennai, Tamil Nadu, India Mewar Technology Services Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Hiring for HIL Validation Engineer – ECUTEST (Contract).Mandatory: ECUTEST, Python, CAN/CAN FD, Ethernet, Vector tools (CANoe), strong Electrical & Electronics basics.Preferred: BMS knowledge, ETAS/dSPACE RCA customer interaction.Location: Chennai

  • Process Validation

    17 hours ago

    Chennai, Tamil Nadu, India HCLTech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesJob Title Manufacturing Engineer/Process Validation EngineerLocation – ChennaiDelivery looking immediate joiner onlyConduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP).Review process controls, equipment validation, and quality systems...

  • Test and Validation Engineer

    2 weeks ago

    Chennai, Tamil Nadu, India Logitech Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Logitech is the Sweet Spot for people who want their actions to have a positive global impact while having the flexibility to do it in their own way.The Team and Role:Are you ready to join a dynamic team dedicated to designing cutting-edge products for a leading company? The audio embedded software engineering group is seeking a talented Quality Assurance...

  • Testing and Validation Engineer

    2 weeks ago

    Chennai, Tamil Nadu, India Expleo Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Minimum 5 years of experience/ 10 years of experience in software testing/validation in a regulated environment.Ability to successfully manage multiple tasks and timelinesAbility to effectively liaise with project team members and other teams/departments, on-site and remotely.Ability to perform and coordinate activities required to bring/maintain systems to...

  • Testing and Validation Engineer-5+ Years

    20 hours ago

    Chennai, Tamil Nadu, India Cortex Consultants Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job Title: Testing and Validation Engineer Location: IN-TN-Chennai   Overview:Minimum 5 years of experience in software testing/validation in a regulated environment.Ability to successfully manage multiple tasks and timelinesAbility to effectively liaise with project team members and other teams/departments, on-site and remotely.Ability to perform and...

  • Business Analyst

    2 days ago

    Chennai, Tamil Nadu, India NowWiN International Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Technical Business Analyst (System Integration)Location:RemoteExperience:8+ yearsType:ContractShift:Night Shift (as per project requirement)Joining:Immediate preferredPosition OverviewWe are seeking an experiencedTechnical Business Analystto lead requirement gathering, analysis, and documentation for complexsystem integration projects.You will collaborate...

  • Finance Data Engineering Analyst

    1 day ago

    Chennai, Tamil Nadu, India VAM Systems Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    As a Data Engineering Analyst at VAM Systems, you will be responsible for supporting the finance team on data and analytics activities and Dataware House (DWH) based on your profound knowledge of banking, financial reporting, and data engineering. - Understanding finance and risk reporting systems/workflow - Participating in system implementation - Having...