Description de l'offre
Orano Med LLC (formerly AREVA Med, LLC). is a subsidiary of Orano group, which has extensive experience in radiochemistry and nuclear facility design. Based on these Orano core competencies, Orano Med, LLC, along with its subsidiary Macrocyclics, is using the promising Alpha radio-immunotherapy to focus on the development of innovative and powerful new pharmaceutical agents to combat cancer.
Orano Group , with 20 000 employees, supplies solutions for power generation with less carbon. Its expertise and unwavering insistence on safety, security, transparency and ethics are setting the standard, and its responsible development is anchored in a process of continuous improvement.
Orano Med is seeking a Biomed Quality Engineer III for our Plano, TX location.
Under minimal supervision, this position is responsible for maintaining and performing IQ/OQ/PQ and/or calibration on equipment and instruments in support of (GMP) manufacturing and testing operations. This position functions efficiently and cooperatively with a team of management, research associates and technicians; analyzes and corrects maintenance/system issues for process efficiency and cost optimization. Independent judgement is crucial for success in this role.
Additional responsibilities will include the following:
· Oversees and directs the calibration and maintenance of GMP/GLP manufacturing and testing operations.
· Leads the maintenance and repair of equipment in support of R&D manufacturing and testing operations.
· Creates, maintains, and reviews qualification protocols and standard operating procedures.
· Troubleshoots technical and functional problems with equipment, instrumentation, and manufacturing processes.
· Frequently interfaces with customers, both internal and external, to develop processes, solve issues, and improve performance.
· Routinely acts as the Lead IQ/OQ/PQ representative for the support of Orano Med projects.
All candidates must meet the following minimum requirements in order to be considered for this position.
· BS plus 4-6 pharmaceutical quality/equipment calibration experience or AS and 6-8 years pharmaceutical quality/equipment calibration experience or HS diploma and 8-10 year of pharmaceutical quality/equipment calibration experience. An advanced degree (MS or MBA) may substitute for 1-2 years of related work experience.
· Possesses and applies a broad knowledge of principles, practices and procedures of particular field of specialization to the completion of difficult assignments.
· High level of accuracy and attention to detail in work very important.
· Excellence in communication skills (verbal and non-verbal).
· Proficiency with PC-based applications such as MS Office, Excel and PowerPoint.
· Ability to interact effectively and with a high degree of professionalism with all levels of staff and management.
· Knows fundamental concepts, practices and procedures of particular field of financial specialization.
The following requirements are desired and will be used to differentiate all candidates who apply for this position.
Knowledge of IQ/OQ/PQ of equipment and analytical methods, calibration of measuring instruments, Agilent, chromatography (HPLC, EC), mass spectrometry (MS), and time oftlight (TOF) systems; GMP, ICH and USP/EP requirements for pharmaceuticals and regulatory and/or compliance/validation issues.
Orano MED (AREVA Med) is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.