Job Description: The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug Substance Manufacturing. T...
Responsibilities: Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones...
Job Summary: We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier quali...
Summary: The CQV Engineer will be responsible for executing commissioning, qualification, and validation testing activities in a GMP pharmaceutical manufacturing environment. This role is strictly focused on test execution, protocol execut...
Roles & Responsibilities : Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management systems Implement and validate Electronic ...
Roles & Responsibilities: Provide an active role within R&D as an expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues. Collaborate with GCP functional areas and assist i...
Job Summary: Study and evaluate current manufacturing practices and identify efficiency improvements Act as the primary technical authority for manufacturing processes, designs, and equipment. Lead efforts to improve manufacturing metho...
Job Description: The Manufacturing Execution System (MES) Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimiza...
Responsibilities: Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regu...
Summary: Perform Quality Engineering activities related to product development and ongoing cleanroom build support Ensure NPD processes comply to quality system and applicable regulatory standards. Update risk management and design cont...