Regulatory Affairs Senior Manager
and Experience: MS in LifeSciences 4-5 years of proven experience in working with the FDA and managing regulatory team in the...
and Experience: MS in LifeSciences 4-5 years of proven experience in working with the FDA and managing regulatory team in the...
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...
or bachelor's degree in LifeSciences, Logistics, Supply Chain, Pharmacy, or related field. 0-3 years of experience in warehouse...
Job Description: As a Manufacturing Program Manager, you are responsible for leading large programs that involve multiple manufacturing, testing and storage locations across the globe. The scope of the programs you lead typically include...
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...
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...
Required Qualifications Education & Experience: Bachelor's degree in Engineering, LifeSciences, Computer Science, or related field 5-8...
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...
Roles & Responsibilities: Leading supplier qualification activities for new components and processes. Planning, executing, and documenting IQ/OQ/PQ and component/process qualifications. Reviewing supplier documentation such as FAIs, pFM...
Summary: Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness...