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 coordinate the correct technical execution of daily operations and GMP procedures for one line in the parenteral manufacturing area and to provide leadership to ensure equipment and associated production systems operate in a safe, efficient, and quality-oriented manner.
Essential Job Functions/Duties
• Coordinate and provide direct support to equipment set-up, operation, changeover, and troubleshooting activities (vial or syringe filler, isolator, debagger, E-beam, lid removal system, depyrogenation tunnel, equipment washer, autoclave, terminal sterilizer, lyophilizer)
• Ensure proper documentation of equipment activities in the BR and logbooks
• Provide recommendations and implement solutions to resolve equipment and or process problems in a timely manner
• Collaborate with Team Lead to execute start-up and clearance activities for the line, equipment, and auxiliary equipment
• Communicate end of shift status and equipment issues to incoming shift and management for smooth operations transition; ensure consistency in operation from shift to shift
• Continuously review batch records and log sheets during production for error or deviation; facilitate corrections; ensure complete documentation at the end of shift
Minimum Work Experience/Educational Requirements
• 2-year degree in Life Sciences, Engineering, or related technical field, or equivalent work experience
• 2+ years in automated machine operation in a production/manufacturing environment required
• Previous pharmaceutical or biopharmaceutical equipment experience (operations, maintenance, or engineering) – preferred
• Previous leadership experience – preferred
• Very strong mechanical skills with solid information technology background
• Will require flexible schedule, to work 12 hour shifts day or night, weekends or holidays
Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 50 pounds on a consistent basis
• Work with hazardous chemicals on a daily basis
• Perform CIP/SIP/sanitization procedures
• Majority of day spent in clean rooms requiring gowning
• Ability to stand for long periods
• Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.)
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...