Responsibilities: Business Analysis and Requirements Gathering Collaborate with stakeholders across R&D and QC labs to identify business needs and translate them into functional and technical requirements. Conduct gap analysis of existi...
Responsibilities: Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk l...
Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migrat...
Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical devi...
Job Description: The Medical Director determines donor eligibility based on applicable standards, regulations and established policies. Responsibilities: Conducts review of medical records, gathers additional donor's screening informa...
Job description: The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development organization. The Biologics CMC Developability team conducts high-throughput screening of physicochemical properties o...
Job Summary: The Process Development Tech II position exists for the processing of human, porcine and fat-based tissue products. It requires clean room gowning and working in a lab setting. The Process Development Tech II serves as a subje...
Responsibilities: Perform risk assessments for manufacturing operations, product quality, and regulatory compliance. Identify, evaluate, and document potential quality risks and propose effective mitigation strategies. Utilize risk asse...
Roles & Responsibilities: Review and approve the documents required to qualify through production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mo...
Responsibilities: Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readine...
Responsibilities: Prepare drug listings and lot distribution reports for biologics. Compile documentation and send certificate of pharmaceutical product requests to the FDA. Manage notarizations and legalization/apostille of regulatory ...
Roles & Responsibilities: Experience in complaint handling for combination products. Familiarity with Trackwise or Veeva. Strong communication skills. An Engineering background in education....
Responsibilities: Perform New Product Development of Surgical Medical Devices in this division, We are looking for an Engineer to perform & work mainly on Quality Tasks. Create, test, and/or improve products by developing moderately comp...
Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation ...
Responsibilities: This position works closely with direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance This position is part of the Regulatory Affairs Co...
Job Description: Performs any combination of tasks involved in the fabrication, manufacture, assembly, testing and packaging of medical devices as well as setting up, operating, performing maintenance on and troubleshooting equipment. May...
Responsibilities: #MedicalDevices Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers. Support decommissioning and recommissioning of equipment. Fundamental knowledge of...