Computer System Validation Engineer

1 day ago

Ahmedabad, Gujarat, India Hiring Embassy Full time ₹ 4,20,000 per year

Computer System Validation Engineer

Job Overview

We are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating the quality of a new software/system. You will be responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.

Experience

1-2 Years

Responsibilities and Duties

· Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP.

· Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side.

· Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5.

· Coordinate with Client to carry out Validation activity of Computerized Systems and Software.

· Responsible for achieving & maintaining the validated status of in-scope computerized systems

· Provide guidance on CSV validation issues and discrepancies

· Support investigation of CSV defects and quality records (deviation, CAPAs).

· Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.

· Coordinating with teammates in achieving assigned tasks.

· Issue/bug tracking, and software incident management.

· Develop and execute test plans to ensure that all objectives are met.

· Implement and monitor test scripts to assess functionality, reliability, performance, and

Coordinate and support to Quality Manager.

· Ensure that user expectations are met during the testing process

· Documentation adherence to internal/Client SOP and compliance.

· Managing department functional process as specified in standard operation procedure & suggest changes if required.

Qualifications

· Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist)

· Excellent written and verbal communication skills.

· Proficiency with MS Office tools

· Documentation management

· Ability to work as a team player in a consulting environment

· Knowledge of Computer System Validation.

· Critical thinker and creative mindset – and the ability to approach a problem creatively.

· A meticulous approach to work.

· A team player but can work independently too.

· Multi-tasking and time-management skills, with the ability to prioritize tasks.

Job Types: Full-time, Permanent

Pay: Up to ₹420,000.00 per year

Benefits:

  • Health insurance
  • Provident Fund

Application Question(s):

  • How soon you can join if get selected? As we are looking for immediate joiners only.
  • what is your current location? (City)
  • What is your current CTC?
  • What is your expected CTC?

Experience:

  • Computer System Validation Engineer: 2 years (Required)

  • Computer System Validation Engineer

    5 days ago

    Ahmedabad, Gujarat, India Nexus pro services Full time ₹ 4,20,000 per year

    Position - Computer System Validation (CSV) EngineerSalary - 4.2LPAExperience - 1-2 YearsLocation - Ahmedabad, GujaratContact person : Working Days - Monday to Friday, 9:30AM to 7:00PMWe are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating...

  • Validation Engineer

    2 weeks ago

    Ahmedabad, Gujarat, India AssureGxP Solutions Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Company DescriptionAssureGxP Solutions empowers life sciences companies with expert Computer System Validation (CSV), Good Practice (GxP) compliance, and auditing support. They offer practical, audit-ready solutions tailored for growing pharmaceutical and biotech teams. AssureGxP Solutions is dedicated to enhancing the operational efficiency and regulatory...

  • Validation Engineer

    1 week ago

    Ahmedabad, Gujarat, India GAMP Services Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptionGAMP Services is a company based in Vadodara, Gujarat, India. We specialize in providing top-notch services in the field of systems validation. Our commitment to excellence and adherence to industry standards ensure that our clients receive reliable and efficient solutions. We are dedicated to fostering a collaborative and innovative work...

  • Computer system Validation

    2 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Veeda Lifesciences Full time

    Primary Responsibility:• To provide support for Bioanalytical systems and users.• Actively support participation in System /Software validation activity and its execution.• Responsible for IT Server and System Backup and restoration process as defined in Sops, must have knowledge documenting the activity as per above mentioned.• Weekly ,Monthly...

  • CSV/PLC Validation Engineer

    2 weeks ago

    Ahmedabad, Gujarat, India Perfect Utilities Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position Overview:We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations...

  • Senior Embedded Hardware Engineer

    1 week ago

    Ahmedabad, Gujarat, India Sahana System Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Summary:We are seeking an experienced and innovative Senior Embedded Hardware Engineer to lead the design, development, and validation of complex embedded hardware systems. You will play a key role in architecting and implementing hardware solutions for products ranging from embedded IoT devices to high-performance embedded systems. This role requires...

  • Rf Engineer

    1 week ago

    Ahmedabad, Gujarat, India Sahana System Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Title: RF EngineerLocation: AhmedabadJob Type: Full-TimeExperience Required: 5-8 yearsAbout our CompanyInfitrone Advanced System Pvt. Ltd a company with the brand name Infinity Radar is the partner of choice for many of the world's leading enterprises, SMEs and technology challengers. Infinity Radar have been honored with three National Awards, and our...

  • System Engineer Battery Management Systems

    7 days ago

    Ahmedabad, Gujarat, India Matter Motors Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesWe are seeking a skilled and motivated BMS System Engineer to join our engineering team. In this role, you will be responsible for the system-level design, integration, validation, and optimization of Battery Management Systems (BMS) for various applications such as electric vehicles, energy storage, and industrial systems. You will...

  • System Engineer

    7 days ago

    Ahmedabad, Gujarat, India Azista Advanced Engineering Group Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    About Azista Advanced Engineering GroupAzista is a leader in aerospace innovation, specializing in spaceborne electronics, avionics, and satellite system integration. We deliver high-performance, space-qualified electronic solutions for commercial and defence applications.Azista is an Equal Opportunity Employer. Interested candidates should submit their...

  • Senior Validation

    7 days ago

    Ahmedabad, Gujarat, India Fact Personnel Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad.Experience : 5+ YearsQualification : B.PharmaRole & responsibilitiesThermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and...