As part of the application process, and in order to be considered for this employment position, you must take and receive a passing score on a Work Keys test administered by Work One. You can make arrangements to take the Work Keys test by contacting Work One at 450 Landmark Avenue, Bloomington, Indiana - Ph 812-331-6000 - ask for Cathy x 224 or Brenda x227.
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.
ESSENTIAL JOB FUNCTION/DUTIES
- To support Drug Product Manufacturing operations – which include the formulation, filling, inspection, labeling, and packaging of injectible products and to support to other associates to ensure systems operate in a safe, effective, and quality-oriented manner.
MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
- Setup, operate, troubleshoot, and clean primary manufacturing equipment including: Vial and/or Syringe Filler, Isolator, De-bagger, E-beam, Lid Removal System, Capper, Washer, Depyrogenation Tunnel, Equipment Washer, Autoclave, Terminal Sterilizer and Lyophilizer.
- Execute aseptic manufacturing procedures using SOPs, batch records, and equipment diagrams
- Inspect components and equipment parts per quality specifications
- Sanitize rooms and equipment, monitor / test environment, dispose of hazardous materials
- Perform environmental monitoring procedures; respond to system alarms
- Transport and/or dispose of hazardous chemicals
- Provide recommendations and implement solutions to resolve equipment and or process problems in a timely manner
- Support the execution of product launch protocols and deliverables
- Document processes according to CGMP requirements
- Participate and support process improvement initiatives
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Ability to work independently and in teams
- Perform basic math skills and applications including addition, subtraction, multiplication and division including the ability to understand decimals
- Written skills necessary to accurately complete paperwork
- Ability to use measuring devices and gauges
- Basic computer entry/retrieval skills
- High school diploma or GED
- Will require flexible schedule – able to work 10-12 hour shifts, or night, weekends, or holidays
- Required to sign confidentiality agreement
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.
- Must be able to lift/push/pull up to 50 pounds on a consistent basis
- Capable of standing for a minimum of 6 hours, stooping, kneeling, climbing
- Potential exposure to hazardous chemicals
- Must be able to wear an air powered or regular respirator
- Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes will be required in areas associated with this position
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...