37 Gamp 5 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...

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,?collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.?Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. Job Description The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk as...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. About the Tech@Lilly Organization: Tech@Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. Wh...

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...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to empower our customers to build a healthier, cleaner, and safer world. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Job Title: Manager Computer System Validation and Assurance Location:...

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to empower our customers to build a healthier, cleaner, and safer world. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing soluti...

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...

BE degree or equivalent work experience in Computer Science, Biology, Biomedical or related field. 7+ years of Computer System Validation/ Product Software Validation testing experience in a regulated environment. Understanding of US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO regulations. e.g., design controls, risk management, and software validation. Self-motivated, willing to learn new concepts, technologies, and products quickly. Excellent interpersonal, writing and communication skills, and troubleshooting skills. Passionate about testing, product quality, and customer satisfaction. It would be a plus if you also possess previous experience in: Software development life cycle (SDLC...

Job Title: Senior Automation Engineer Pharmaceutical Manufacturing Location: Remote Experience: 10+ years Industry: Pharmaceutical / Biotech Manufacturing Job Summary: The Senior Automation Engineer is responsible for driving automation initiatives across pharmaceutical manufacturing systems, ensuring compliance with GMP, and enhancing equipment reliability and process efficiency. This role involves overseeing automation design, programming, validation, and maintenance of PLC, SCADA, and related control systems used in production and utility areas. Key Responsibilities: Managed automation systems supporting production, utilities, and cleanroom environments in compliance with GMP and regulato...

HighByte/UNS Validation Engineer – LifeSciences: 5+ yrs exp in HighByte Intelligence Hub, UNS, MQTT/OPC UA, REST API, Python/JSON. Strong in GxP, 21 CFR Part 11, GAMP5 validation, MES/LIMS/ERP testing & ALM/JIRA tools.

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

Job Title: Senior Trainer Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal candidate should have in-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles , and be capable of delivering engaging, practical training to QA, QC, Manufacturing, and IT professionals. Key Responsibilities: Develop, design, and deliver training programs on Computerized System Validation (CSV) and Data Integrity (A...

Job Title: Senior Automation Engineer Pharmaceutical Manufacturing Location: Remote Experience: 10+ years Industry: Pharmaceutical / Biotech Manufacturing Job Summary: The Senior Automation Engineer is responsible for driving automation initiatives across pharmaceutical manufacturing systems, ensuring compliance with GMP, and enhancing equipment reliability and process efficiency. This role involves overseeing automation design, programming, validation, and maintenance of PLC, SCADA, and related control systems used in production and utility areas. Key Responsibilities: Managed automation systems supporting production, utilities, and cleanroom environments in compliance with GMP and regulato...

About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards. Key Responsibilities: Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications. Ensure all software, cloud platforms, and supporting infrastructure comply wi...

About the Tech@Lilly Organization : u00A0 Tech@Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Tech@Lilly is that we create new possibilities through tech to advance our purpose u2013 creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise. u00A0 About the Business Function : u00A0 u00A0 The Tech@Lilly Digital Office (DO) and Glo...

Skills: GAMP 5, 21 CFR Part 11, IQ, OQ, PQ, CSV, Immediate Hiring | Computer System Validation (CSV) Pharma Industry Were looking for passionate professionals to join our team in the Computer System Validation (CSV) role. Location: Indore (M.P) Industry: Pharma Role: Computer System Validation Engineer Experience: Minimum 1 year (in Pharma domain preferred) Notice Period: Immediate Joiners to 30 days Key Responsibilities & Skills Preparation and execution of Validation Deliverables in accordance with GAMP5 and 21 CFR Part 11 guidelines. Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ, and validation of manufacturing systems (SCADA, HMI, PLC). Conduct and document Computer System...

We're currently hiring for our US-based global management consulting and technology client, a market leader in healthcare and life sciences. Headquartered in Illinois (USA) and present across 30+ countries, the firm employs over 17,000 professionals worldwide across consulting, technology, and business operations. It will start off as a 9-month-long contract with possible conversion to a full-time role; the contract will be extended. If you're passionate about building cutting-edge applications and working with the latest in AI, this could be a great fit! We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulator...

Job Title: Automation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Automation Trainer with a strong background in pharmaceutical manufacturing automation systems . The ideal candidate will design, deliver, and evaluate training programs focused on automation technologies, PLC/SCADA systems, process control, validation, and equipment integration in regulated pharma environments (GMP/GxP). Key Responsibilities: Develop and conduct comprehensive training programs on automation systems used in pharmaceutical production , such as PLCs, DCS, SCADA, and MES. Train and mentor engineers, technicians, and operators on automation troubles...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological re...

Focus Areas: CSV: Strong knowledge of FDA, GAMP 5 , and global regulations ( US, EU, TGA ; Japan a plus) Equipment/Utility Qualification: Installation/operational/performance qualification, risk assessment, CAPA Process/Cleaning/Method Validation: Oral solid, topical, spray forms preferred Responsibilities: Lead and manage validation projects across global sites, develop SOPs and standards, ensure compliance (cGMP, ISO, WHO), perform risk and gap analyses, support audits and CAPA, and mentor site teams via COP forums. Ideal Profile: Strong in CSV plus complementary experience in equipment/utility; capable of designing validation strategies and managing cross-functional teams. Interested cand...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

Planning and performing of Computer Systems Validation in regulated environment. Respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. IT systems interface Required Candidate profile Working knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Develop CFR Part 11 csv plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols; IT system interface

Job Description: What are we looking for Analysts Consultants Senior Consultants We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experience Understanding of key pharmaceutical compliance regulati...

Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological re...