11 of 11 GAMP Jobs

self-motivated. Desirable Qualifications Experience in embedded software or automation systems. Understanding of industrial protocols (e.g., OPC UA). Exposure to traceability and validation in regulated domains (e.g., GxP, GAMP). Tools Primary: Azure DevOps Secondary: Polarion Business Analyst/Requirement Engineer - (Software Requirements & DevOps More ❯

Have Familiarity with basic networking/routing/switching concepts Experience with storage performance tuning and capacity planning Previous experience in pharma, biotech, or life sciences environments Knowledge of GAMP or similar compliance frameworks Key Responsibilities Manage and optimize storage hardware and software, ensuring performance, availability, and reliability. Implement and maintain backup and disaster recovery solutions, performing regular testing and More ❯

data engineering, and business stakeholders, to ensure successful implementation of smart factory and digital transformation initiatives. Ensure all solutions comply with relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5) and industry best practices. Client Engagement & Advisory: Act as a trusted advisor to clients, translating business challenges into actionable technical solutions. Conduct workshops, technical assessments, and roadmap planning sessions More ❯

assessments and impact analyses for software changes. Document verification and validation results and maintain traceability matrices. Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5). Support audits and inspections by providing validation documentation. Test Planning and Design Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications. More ❯

decision-making abilities Ability to translate complex technical concepts into clear business value Experience with Agile methodologies and product management tools (e.g., Jira, Aha!, Confluence) Familiarity with ISA-95, GAMP 5, and other industry standards Experience working with cloud-based MES platforms and integration with ERP/LIMS systems Familiar to work in a multicultural environment, with teams geographically distributed More ❯

and testing regiments. Experience writing software applications and web services using PI-SDK and AF-SDK Experience installing and configuring web-based applications. Requirements: Familiarity with ISA 88 and GAMP Minumim over 5+ years relevant industry PI experience Pharma industry experience perferred but not essential PI System Training Bachelor's Degree in appropriate field of study or equivalent work experience More ❯

on client’s site, no remote working • Working on regulated environment (GxP based) Skills: • Applying OS image on Laptop/Computer • 21 CFR Part 11 • 21 CFR Part 820 • GAMP 5 • Manual Testing, Qualification process More ❯

troubleshooting, and time management skills. Excellent communication and teamwork abilities. Desirable: Knowledge of unit testing, integration testing, and mocking frameworks. Experience working in regulated industries or validated environments (e.g., GAMP). Location: Ipswich (hybrid More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Good automated manufacturing practice (GAMP). Very good communication skills and demonstratable experience of working as part of cross functional teams. Experienced in working with cross functional teams to identify and implement changes and improvements More ❯

isolator and containment equipment. You’ll work within a flexible, multi-skilled team to design, test, and implement PLC and SCADA/HMI solutions — ensuring compliance with GxP and GAMP standards. This hands-on position combines software design , system integration , and field service/commissioning both in the UK and internationally. Key Responsibilities Provide service, software, and commissioning support to … develop, and test PLC & SCADA control systems for upgrade and retrofit projects. Manage data communications with third-party equipment and systems. Validate and document software designs in line with GAMP and pharmaceutical standards. Promote and implement Syntegon Telstar standard design practices to improve efficiency and cost-effectiveness. Provide remote and onsite technical support , including troubleshooting and commissioning. Travel within the … work directly with customers IT literacy for industrial applications Desirable: Knowledge of Rockwell Studio 5000/FactoryTalk Experience with isolator or barrier systems Background in pharmaceutical or regulated industries (GAMP, GMP, FDA) Why Join Us? Be part of a global leader in aseptic and containment technology Work in a highly skilled, multidisciplinary engineering team Opportunities for international travel and technical More ❯