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 support validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
Essential Job Functions/Duties
• Coordinate multiple projects to provide documented validation of equipment, control systems, cGMP utilities and manufacturing processes
• 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
• Conduct enhanced design reviews for relevant process equipment
• Assess risks involved in processing steps and related to equipment
• Develop and review validation requirements and design deliverables
• Ensure facility validation strategies and policies are followed
• Coordinate process validation projects as needed
Minimum Work Experience/Educational Requirements
• Bachelor Degree in Life Sciences, Chemical Engineering or Mechanical Engineering or equivalent experience
• 2 – 4 years of Validation or pharmaceutical Process Engineering experience
• Perform basic math skills and applications including addition, subtraction, multiplication and division including the ability to understand decimals
• Ability to coordinate efforts of various departments and contractors
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...