26 Validation Documentation Jobs

Job Posting Title India Remote/Ahmedabad/Bengaluru/New Delhi Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients lives and act accord...

As an experienced candidate with 4-5 years in validation documentation, you will be responsible for preparing Machine DQ, IQ, OQ, PQ, operational manuals, and all supporting documents in accordance with customer requirements. Key Responsibilities: - Minimum 4-5 years of experience in validation documentation - Preparation of Machine DQ, IQ, OQ, PQ, operational manuals, and supporting documents as per customer requirements Qualifications Required: - Relevant experience in validation documentation - Strong attention to detail - Ability to work in compliance with customer requirements The company offers the following benefits: - Cell phone reimbursement - Food provided - Internet reimbursement ...

Assist in the validation of Track and Trace and Inspection systems, including drafting and executing IQ, OQ, IOQ and PQ protocols. Support system verification activities to ensure compliance with 21 CFR Part 11 and other regulatory standards. Collaborate with cross-functional teams (Development, Engineering, IT, PMO, Production, Service) during implementation and testing phases. Review and maintain validation documentation, including test scripts, deviation reports, and traceability matrices. Monitor and report system performance, helping to identify non-conformities and supporting CAPA activities. Participate in audits and inspections, providing validation records and technical support as n...

As a Specialist in the Site MS&T team within the Large Molecules Platform at Novartis Healthcare Private Limited in Hyderabad, India, you will work closely with multifunctional technical operations teams. Your role involves executing and supporting Technical Transfers and Life Cycle Management activities, with a strong emphasis on preparing and updating Risk assessments and Validation related documentation. Key Responsibilities: - Utilize Validation and Life Cycle Management Expertise to prepare process and cleaning validation documentation, conduct change evaluations, and ensure compliance with cGMP requirements - Support process validation lifecycle activities and participate in pre-valida...

Job Description As a Senior Lab Informatics Specialist, you will lead the deployment, customization, and optimization of Agilent's informatics solutions (OpenLab CDS server, etc.) across complex laboratory environments. You will act as a strategic advisor to clients, ensuring seamless integration of lab systems, regulatory compliance, and digital transformation. Key Responsibilities: Lead end-to-end implementation of Server client networks and OpenLab platforms in regulated labs. Architect integration solutions between lab instruments with Servers and enterprise systems (ERP, MES). Drive customer workshops to gather requirements and design tailored informatics workflows. Ensure compliance wi...

As a Validation Lead Engineer at our company, you will play a crucial role in overseeing end-to-end validation activities to ensure regulatory compliance and high-quality execution. Your strategic leadership and hands-on documentation expertise will be key in utilizing a risk-based approach to validation and testing. Key Responsibilities: - Lead validation planning, strategy development, and execution in order to meet project and regulatory requirements effectively. - Prepare and review comprehensive validation documentation, including protocols, reports, and other related deliverables. - Collaborate closely with testing teams to ensure that the execution aligns with requirements and maintai...

What you will do: Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira). Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups Develop and execute validation strategies and plans for new and existing computerized systems. Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceabil...

Configure and maintain Safety and Medical information database. Manage user accounts, roles, and access controls. Perform routine system checks and maintenance tasks. Provide support during system implementation and post-go-live phases. Act as first-level support for database-related issues via the internal helpdesk tool. Troubleshoot and resolve technical issues in collaboration with IT and vendor teams. Assist in the creation and execution of validation documentation (URS, FRS, IQ/OQ/PQ). Ensure systems comply with GxP, 21 CFR Part 11, and other relevant regulations. Develop and update training materials for end-users. Conduct training sessions and onboarding for new users. Support interna...

As a Clinical Validation Specialist at Philips Enterprise Informatics (EI), you will be part of the Clinical Excellence team, contributing to the clinical validation of products, applications, and solutions across various Philips EI domains. Your role will involve collaborating with different departments and Business Innovation Units to ensure regulatory compliance and customer satisfaction. **Key Responsibilities:** - Support the validation of innovative (AI) solutions and technologies to address identified needs and challenges. - Ensure that innovations are safe, effective, and compliant with regulatory standards to improve patient outcomes. - Plan, coordinate, and lead validation activiti...

As a B.Sc./Diploma holder or B.E in ECE, EEE, or EIE with a minimum of 2 to 4 years of servicing experience on Pharmaceutical or Biotechnology laboratory equipment, you will be responsible for the following: - Customer support- Installation - Managing installation and commissioning - Understanding customer product and site requirements - Resolving issues at customer site - Ensuring that guidelines and standards of work expected by Saksham are understood and met - Providing training to customers on operating the equipment - Providing supervisory and technical support to colleagues and communicating with staff at all levels - Understanding new equipment/technology Your responsibilities will al...

**Job Description:** As a Process Engineer, your role involves reviewing the process flow according to customer requirements and developing process flows for pharmaceutical formulations. You will work closely with the project manager to conduct capacity and cycle time analysis, define equipment sizing, and create technical specifications (TS) and data sheets for production, packaging, and process equipment. Your responsibilities will also include floating inquiries to vendors, resolving technical queries, and following up with vendors for offers. Additionally, you will organize meetings with vendors, create a make/vendor list of production machinery within the project budget, and participate...

OPTEL. Responsible. Agile. Innovative. OPTEL is a global company that develops transformative software, middleware and hardware solutions to secure and ensure supply chain compliance in major industry sectors such as pharmaceuticals and food, with the goal of reducing the effects of climate change and enabling sustainable living. If you are driven by the desire to contribute to a better world while working in a dynamic and collaborative environment, then you've come to the right place! Validation Specialist Trainee Summary The Validation Specialist is responsible for creating and maintaining validation documents, such as internal validation protocols, Installation Qualification (IQ), Operati...

As a skilled and detail-oriented GxP Validation Tester with over 3 years of experience in software testing within regulated environments, you will be responsible for conducting GxP validation and compliance testing of applications to ensure adherence to FDA/EMA guidelines. Your expertise in database testing using SQL, Unix commands, and knowledge of Azure cloud environments will be crucial in ensuring the quality and accuracy of data systems. Collaboration with development and DevOps teams is essential to ensure end-to-end system functionality. Key Responsibilities: - Execute test cases on Unix-based environments - Prepare and maintain validation documentation - Support cloud-based testing a...

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. Job Description 3-6 Years resource for Bangalore Work with global multi-functional project teams to support on technical and SAP documentation Manage sustenance engineering tasks for medical pro...

Role Overview: Join Amgen's mission of serving patients by becoming a key member of the team that helps research, manufacture, and deliver innovative medicines to improve patients" lives. As part of Amgen, you will have the opportunity to make a lasting impact on patients while transforming your career. The culture at Amgen is collaborative, innovative, and science-based, providing you with a challenging yet rewarding environment to thrive in. Key Responsibilities: - Lead the execution of complex or novel assignments requiring strategic planning and development of new validation techniques - Supervise validation activities, conduct risk assessments, and establish policies for computer system...

As a MES Consultant or Recipe Author, you should have experience in Rockwell PharmaSuite MES and a solid understanding of pharmaceutical manufacturing processes, particularly in solid oral dose and packaging. Your skills should encompass EBR design and configuration, validation documentation, and ensuring GMP compliance. Proficiency in tools such as Microsoft Visio, Rockwell PharmaSuite, and any legacy EBR tools like P2C2 and PMX is essential for this role. Having experience in working with Italian clients would be a bonus, especially if you possess Italian language proficiency. The preferred start date for this position is July 1, 2025. The job locations available for this role are in India...

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

The job is located in Mumbai and Pune. You should have a B.Sc./Diploma/B.E in ECE, EEE, EIE qualification. This position is for male candidates. You should have a minimum of 2 to 4 years of servicing experience on Pharmaceutical or Biotechnology laboratory equipment. Your responsibilities will include: - Customer support and installation - Managing installation and commissioning - Understanding customer product and site requirements - Resolving issues at customer sites - Ensuring guidelines and standards are met - Providing training to customers - Providing supervisory and technical support to colleagues - Understanding new equipment and technology - Generating AMC revenue, service revenue, ...

As a Validation Specialist, you will be responsible for leading and conducting Computer Systems Validation (CSV) activities for IT systems utilized in pharmaceutical manufacturing settings. Your role will involve authoring comprehensive validation documentation, overseeing system validation and deployment, ensuring compliance with regulatory guidelines, managing compliance, conducting testing and quality assurance activities, contributing to Agile practices, and engaging with various stakeholders. You will be tasked with creating Validation Plans, Test Plans, and Requirements Specifications, as well as developing and executing Installation Qualification (IQ), Operational Qualification (OQ), ...

Seeking a driven Pharma IT Sales Executive to lead growth in pharma/life sciences. Must excel in consultative sales, positioning validation, compliance, audits. Engage CXOs, QA, IT heads with trusted, value-driven solutions. Regulatory standards

The job is located in Mumbai and Pune and requires a candidate with a qualification of B.Sc./Diploma holder /B.E in ECE, EEE, EIE. The position is open for male candidates with a minimum of 2 to 4 years of servicing experience on Pharmaceutical or Biotechnology laboratory equipment. The products involved include Process Equipment/Autoclave, Washers, DHS, Isolator, Glove box, Pure steam generator, and multiple Distiller, Fermenter. The customers serviced are Pharmaceutical Companies. Job responsibilities include customer support such as installation, managing installation and commissioning, understanding customer product and site requirements, resolving issues at customer site, ensuring guide...

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Ba...

You should have knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. It is essential to collaborate effectively with developers and stakeholders to proactively understand and analyze the application requirements. Your responsibility will include creating comprehensive test cases and scenarios based on risk-based approaches, with a specific focus on critical functionalities and compliance aspects of the application. You must ensure that the test cases are traceable to the system requirements and risk assessments. Additionally, you will be required to execute IQ/OQ/PQ to validate the application. It will also be your duty to log, track, and manage defects identified during tes...

Role & responsibilities Validation Engineer • Expertise in preparing end-to-end validation documentation including protocols and reports. Collaborates closely with the testing team to ensure execution aligns with requirements. • Should utilize a risk-based approach for validation/testing. Veeva tool Preferred candidate profile

Develop and execute manual test scripts, create validation artifacts (IQ/OQ/PQ, UAT), perform dry runs and defect retests, trace requirements, collaborate with cross-functional teams, and support agile-based QA across Veeva Vault applications. Required Candidate profile Manual QA professional with 2+ years in Veeva Vault testing, experience in validation documentation, agile SDLC, pharma domain exposure. Preferably familiar with SFDC/Veeva CRM and basic automation