Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.
• To provide calibration support for facility and manufacturing critical systems in a biotechnical facility by testing and calibrating electrical, mechanical, electromechanical, analytical and electronic measuring, recording and indicating instruments and equipment for conformance to established standards.
ESSENTIAL JOB FUNCTION/DUTIES
• Perform scheduled calibration on instrumentation and control devices in compliance with facility procedures and work instructions, and in a cGMP and ISO compliant manner
• Assist in the maintenance and support of the calibration database
• Continuously evaluate all SOP’s and calibration procedures for accuracy and applicability, and submit appropriate change requests to correct any deficiencies discovered
• Assist in scheduling and coordination of outside services for support of the calibration program
• Assist Process Engineers on development projects as needed and provide training to maintenance and production employees on calibration techniques
• Work with various chemicals, steam and pressurized gases/liquids at various temperatures as part of some calibration procedures
• Provide assistance in training others on calibration techniques
MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
• ASQ Certification as a Calibration Technician is a plus
• Previous experience in the biotechnical or pharmaceutical industry is desired
• AA/AS Degree in a science or engineering major preferred
• Working knowledge of 21CFR and cGMP regulations
• Work experience in a clean room environment
• Must possess good written and oral skills
• High school diploma or GED
• 5+ years experience in calibration of equipment and instruments (calibration experience must include thermocouples, transmitters and recorders)
• Requires signed confidentiality agreement
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
• Must be able to lift/push/pull up to 80 pounds on a consistent basis
• May work on the manufacturing floor in classified areas requiring gowning
• Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.)
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
• Potential limited exposure to gases, chemicals, fumes, odors, mists and dusts, and other hazardous materials
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...