18 Validation Documentation Jobs

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

Job Summary: We are seeking a highly skilled and detail-oriented Computer System Validation (CSV) Consultant with proven experience in validating SAP systems (SAP ECC, SAP S/4HANA, SAP GxP modules, etc.) within regulated environments such as the pharmaceutical, biotechnology, or life sciences industries . The ideal candidate will be responsible for ensuring SAP systems are compliant with GxP regulations, 21 CFR Part 11, Annex 11 , and other applicable standards by leading and executing validation activities throughout the system lifecycle. Key Responsibilities: Lead and perform CSV activities for SAP systems, including validation planning, risk assessments, and test script development (IQ/OQ...