About Aura. At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies. We are focusing the initial development of our VDC technolo...
. Job Description. cGMP Consulting is looking for an individual to manage the Validation personnel. This individual will oversee validation activities related to equipment and computerized system qualifications and re-qualifications. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. This position is direct hire. Responsibilities. Manage a team of Principal, Senior and entr...
Summary. The Validation Manager reporting into Facility Director/Head of Facilities with dotted line reporting to the Senior Director of Quality will oversee the validation program at New Horizon (NH), ensure all equipment, processes, and systems are validated and in compliance. Principal. Duties/Responsibilities. . Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminal...
Why Patients Need You. Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve. All o...
Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing t...
Company DescriptionA Few Words About Us. Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT),...
Position Summary. The Manager of Systems Engineering responsible filling role as both technical expert for product validation and people leader of the Validation Engineering team. Main Duties and Responsibilities. Manage Validation Engineering resources for the program, and provide programmatic and proposal support. Provide oversight and support to critical program area Engineering skill development, which includes critical Test and Integration. ...
Summary of Primary Responsibilities. This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidel...
