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 participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
Essential Job Functions/Duties
• Manage multiple projects to provide documented validation of equipment, control systems, cGMP utilities and manufacturing processes
• Develop process validation master plans according to client processing steps
• Review process flow diagrams and perform risk analysis
• Schedule and sequence validation deliverables
• Review of equipment submittals and design specifications
• Analyze data associated with validation protocols
• Develop and review functional requirements specifications as related to process equipment
• Develop and/or review user requirement specifications
• Develop and review facility impact and component criticality assessments
• Develop validation protocols and associated summary reports
• Review facility change logs and provide input on revalidation activities
• Serve as an interface to process development and tech transfer teams
• Conduct design qualification for relevant process equipment
• Develop and review validation requirements and design deliverables
• Ensure facility validation strategies and policies are followed
• Lead validation projects as needed
• Provide schedule integration for validation projects
Minimum Work Experience/Educational Requirements
• Bachelors Degree in Life Sciences, Chemical Engineering or Mechanical Engineering or equivalent experience
• Minimum of 4 years of Validation or pharmaceutical process engineering experience
• Excellent oral and written communication skills and computer literacy skills.
Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 30 pounds on an occasional basis
• Ability to work at a computer desk setting for majority of the day
• 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
• Limited exposure to hazardous chemicals while in manufacturing environment
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...