- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- Sumitomo Pharma (Annapolis, MD)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- United Therapeutics (Silver Spring, MD)
- …prioritize workload + Manufacturing or Quality system application support experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Oracle (Annapolis, MD)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Koniag Government Services (Silver Spring, MD)
- …regulatory applications and scientific reports, ensuring accuracy and completeness + Utilize FDA -provided Oracle or Access databases, or other computer systems, ... for data input as required + Perform data validation and quality control functions to maintain data integrity...+ Proficiency in using databases (eg, Oracle, Access) and computer systems for data input and management + Strong… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …make vision a reality. Project Description: This project is designed to support FDA CDER Office of Quality Surveillance (OQS) with developing and implementing modern ... serves as a technical specialist leveraging expertise in data science, computer science, mathematics, and statistics to transform complex clinical data into… more
- United Therapeutics (Silver Spring, MD)
- …and JCI Metasys experience + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + PLC ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Terumo Medical Corporation (Elkton, MD)
- …but is not limited to, the understanding of change control, validation , documentation practices, process control and design control requirements. 5. Contribute ... be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 2. Performs other job related… more
- United Therapeutics (Silver Spring, MD)
- …procurement and utilization + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- GRAIL (Annapolis, MD)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
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