Instrumentation Specialist-223948

Seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.

Job Responsibilities:

• Oversee IQ/OQ/PQ for new instruments
• Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports)
• Equipment/service logs: establish, review, maintain
• URS for equipment: Assist with drafting/review/approval
• Responsible for a variety of cGMP and non-cGMP instruments including:
• Production: preparatory LC, fluid transfer, dispensing, weighing, EM
• QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes
• Hot cells: VPHP, EM, fill/finish, other sensors/controls
• Safety: radiation detectors for personnel, surfaces, air
• General: refrigerators/freezers, incubators
• Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc.
• Work with instrument operators to develop robust protocols for system suitability checks for equipment
• Assist with vendor qualifications
• Top Priority: On-Time Production/Release of Product Batch Release
• All tasks from the Setup Phase that continue into Production Phase.
• Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status.
• Preparation of calibration certificates and data reports using appropriate Quality documentation.
• Ensuring that the equipment is calibrated as per specifications and industry standards.
• Oversee warranties, PMs, scheduled recalibration/requalification
• Scheduling appointments for equipment maintenance and servicing.
• Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks
• Testing repaired equipment to verify qualified status
• Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies.
• Expert on instrumentation: liaison to management/inspectors
• Write protocols for in-house calibrations/qualifications
• Analyze/suggest equipment upgrades and software
• Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.)
• Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.