Client: Biopharmaceutical Company. What You'll Do. Drive cleaning validation projects, including spray coverage testing and lab-scale studies. Prepare and execute validation protocols (FAT, SAT, IQ, OQ, PQ). Conduct risk assessments, gap analyses, and periodic reviews. Partner with cross-functional teams on deviations, change controls, and continuous improvements. Ensure compliance with FDA, EU, and other regulatory standards. What We're Looking ...
Client: Biopharmaceutical Company. What You’ll Do. Drive cleaning validation projects, including spray coverage testing and lab-scale studies. Prepare and execute validation protocols (FAT, SAT, IQ, OQ, PQ). Conduct risk assessments, gap analyses, and periodic reviews. Partner with cross-functional teams on deviations, change controls, and continuous improvements. Ensure compliance with FDA, EU, and other regulatory standards. What We’re Looking ...
Roles & Responsibilities. Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT com...
Roles & Responsibilities. Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT com...
Role & Responsibilities. Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analysis Data and Reports Findings Compiles and analyses validation data, writes com...
Role & Responsibilities. Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analysis Data and Reports Findings Compiles and analyses validation data, writes com...
Job Details. Position Summary. The Validation Engineer is responsible for development and execution of validation and commissioning protocols for general equipment in Biopharma facility. The position requires general knowledge of Biopharmaceutical equipment, cGMP, and GDP. This position is 100% onsite with no remote work. Duties. Perform and support execution of validation protocols/projects. Develop, review, and redline URS/FRS/DDS. Support chan...
Introduction. Help ensure quality and compliance in pharmaceutical manufacturing. Our client is seeking an experienced. CQV Engineer. to support the commissioning, qualification, and validation of equipment, utilities, and facilities in a GMP-regulated environment. This role is critical in ensuring systems are qualified in alignment with industry standards and regulatory expectations. This role will offer you. Be part of a high-impact capital pro...
Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess dev...
Along with Engineering Staff, QA Director/QA Manager and Compliance Manager, develop and implement updates to the Master Validation Plan for the packaging facility. Establish, document and manage the Bioburden Monitoring, Compressed Air Point of Use and Calibration programs.- Develops a thorough understanding of RL Packaging Equipment and Processes- Develops and documents change controls, validation plans, qualification protocols, associated repo...
Quality Specialist - UK, Bedford - 11 Months Initial Contract. Do you want to be involved with exciting pharmaceutical projects. When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence. employing more than 1000 people. They are looking to add to their team and require a Quality Specialist. Essential Duties and Responsibilities ...
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