1 to 25 of 76 GMP Jobs

Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows ...

integration solutions meet applicable GxP requirements and organizational quality standards. Apply relevant requirements and principles, including FDA 21 CFR Part 11 and EU GMP Annex 11 where applicable, ALCOA+ data integrity principles, and Good Documentation Practices. Support requirements definition, risk assessments, traceability, testing, qualification, and validation activities. Collaborate with Quality ...

data flow issues. Compliance & Documentation Maintain documentation for MES configurations, SOPs, workflows, validation protocols, and system changes. Support compliance with FDA, USDA, HACCP, SQF, GMP, and internal quality standards. Participate in change management, system testing, validation, and deployment activities. Assist with user training and development of work instructions. Required Qualifications ...

Requirements Bachelors degree in chemistry, biochemistry, pharmaceutical science, or a related field. 57 years of QC analytical experience in pharmaceutical, biotechnology, API, or another GMP-regulated laboratory. Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices. Hands-on experience with relevant chromatographic ...

preferably within pharmaceutical, biotechnology, medical device, or another highly regulated industry.Demonstrated experience troubleshooting and supporting automated manufacturing or packaging equipment .Experience working within a GMP/GxP-regulated manufacturing environment .Ability to troubleshoot complex equipment problems involving multiple disciplines, including mechanical, electrical, controls, and automation systems.Experience supporting equipment changes through ...

within pharmaceutical, biotechnology, medical device, or another highly regulated industry. Demonstrated experience troubleshooting and supporting automated manufacturing or packaging equipment. Experience working within a GMP/GxP‐regulated manufacturing environment. Ability to troubleshoot complex equipment problems involving multiple disciplines, including mechanical, electrical, controls, and automation systems. Experience supporting equipment changes ...

Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

retesting activities through to closure. Desirable Experience Familiarity with Computer Software Assurance (CSA) and risk-based assurance principles. Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and relevant data integrity guidance. Experience testing enterprise systems such as MES, ERP, LIMS, QMS or other regulated business ...

external tools Interpreting lab data and presenting insights 7. Regulatory and compliance knowledge GxP, FDA 21 CFR Part 11, ISO 17025 and GMP Electronic signatures, audit trails and data validation processes 8. Infrastructure and environment Windows Server environments On-premise and cloud-hosted deployment models Security: authentication, authorisation and data ...

teams needs, challenges and requirements. Develop strategies to leverage Salesforce Media Cloud for centralizing and monetizing ad inventory across platforms like Google Marketing Platform (GMP); Meta Ads; Criteo and LinkedIn and more. Provide expert advice on best practices for ad operations, inventory optimization, and revenue growth. Implementation and Configuration Lead ...

Experience in troubleshooting basic electrical control systems. Extensive experience in Rockwell hardware and software applications (Studio5000), Wonderware In Touch and Middleware. Awareness of FDA & GMP/GAMP regulation and validation in the pharmaceutical or food industry. Salary: $87,945.30 to $121,655.00 per year Bonus Eligibility: Yes The pay range ...

development of medicines that improve patients' lives worldwide. Job Responsibilities Main Duties include: Provide data science support as ARD Digital Transformation team partners with GMP-Analytics, Drug Substance (API) and Drug Product (DPA), and Degradation Science and Structural Elucidation (DSSE) teams to digitise laboratory workflows Partner with Data Science teams ...

Microsoft 365 Group Policy Software Deployment and Release Management Desirable Experience Experience working within pharmaceutical, biotechnology, life sciences, or other regulated industries. Exposure to GMP, GxP, or validated environments. Experience supporting device refresh, Windows 11 migration, or large-scale workplace transformation programmes. Familiarity with application validation and compliance-driven change ...

Microsoft 365 Group Policy Software Deployment and Release Management Desirable Experience Experience working within pharmaceutical, biotechnology, life sciences, or other regulated industries. Exposure to GMP, GxP, or validated environments. Experience supporting device refresh, Windows 11 migration, or large-scale workplace transformation programmes. Familiarity with application validation and compliance-driven change ...

experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data ...

contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous ...

data standards and governance in regulated environments.Preferred qualificationsIf you have the following characteristics, it would be a plus:Advanced degree in Life Sciences.Experience with GMP environment.Deep understanding of LabWare ELN/LIMS.Formal product or agile certification (for example CSPO, SAFe PO/PM).Experience with product management tools such ...

governance in regulated environments. Preferred qualifications If you have the following characteristics, it would be a plus: Advanced degree in Life Sciences. Experience with GMP environment. Deep understanding of LabWare ELN/LIMS. Formal product or agile certification (for example CSPO, SAFe PO/PM). Experience with product management ...

would be a plus if you also possess previous experience in: Experience in medical devices or similarly regulated environments, including Good Manufacturing Practices (GMP) and quality systems. Hands-on experience supporting Digital Pathology systems, especially the Aperio GT Platform, Aperio FL, CytoVision/CytoInsight, or VERSA; familiarity with Windows Server ...

experience in IT project coordination, technical requirements capture and readiness within regulated manufacturing environments. Regulated manufacturing and life sciences expertise , including GxP/GMP environments, Computer Systems Validation (CSV), and experience in pharmaceutical or life sciences manufacturing (desirable). Technical domain knowledge across Manufacturing IT and Operational Technology (OT), Laboratory ...

feasibility studies and recommend appropriate technical developments. Deliver defined digital project workstreams and maintain clear technical and user documentation. Work in accordance with applicable GMP requirements, regulatory expectations, site procedures and the Pharmaceutical Quality System. Skills and experience required You will bring: Experience applying data, reporting, process improvement and digital ...

seeking an experienced Technical Architect to support a large-scale enterprise device migration and workplace transformation programme, within a highly regulated pharmaceutical GMP environment. The role will define, guide, and assure the end-to-end architecture across infrastructure, identity, networking, and security domains within a complex enterprise environment. The successful ...

across the pharmaceutical supply chain. Responsibilities Architect and deploy comprehensive SAP S/4HANA solutions tailored for Production Planning and Quality Management in a GMP-compliant environment. Manage the full lifecycle of pharmaceutical implementations, from initial requirements gathering to go-live support and post-implementation optimization. Configure and oversee ...

. Experience with process control and automated systems for production lines. Familiarilty with PID tuning for production lines. Familiarity with industry-specific regulations (HACCP, GMP, etc.) and food safety standards. Knowledge of instrumentation and process equipment . Knowledge of Java, Python, C++ and VB Scripting Familiarity with Flow Charts ...

collected for testing schedules and testing schedules are met Logging micro samples Accurate carrying out of positive release checks for all finished products GMP audits/Glass and plastic audits, including generation of improvement areas, completing database Ensure close outs of non-conformances Sampling and recording of finished product shelf ...