Validation Associate - Cook Pharmica
Cook Medical 37 reviews - Bloomington, IN

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  • To support validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.


Essential Functions:
  • 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

Additional responsibilities:
  • Partner with contract validation teams to support and monitor efforts
  • Review equipment submittals and design specifications

  • Identify and report possible exceptions to SOP’s
  • Identify and report possible preventive and corrective actions
  • Identify and report potential hazards either safety or ergonomic
  • Identify and report safety and environmental hazards
  • Analyze validation data and report results
  • Identify exceptions associated with validation protocol execution
  • Review and revise SOPs as required

  • Bachelors Degree in Life Sciences, Chemical Engineering or Mechanical Engineering or equivalent experience
  • Sign company required confidentiality and non-compete agreement
  • 2-4 years of validation or pharmaceutical process engineering experience

  • Ability to effectively communicate with co-workers as well as management
  • Basic computer skills including Microsoft Office applications
  • 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
  • Ability to work with Kaye Validator System and or other temperature logging devices

· Responsible for completing assigned tasks by due dates
· Responsible for the initiating and completing investigations in a timely manner
· Responsible for compliance to company’s Quality Policy Manual
· Responsible for compliance with company’s safety policies
· Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
  • Responsible for compliance of Corporate Code of Conduct

  • 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
  • Potential limited exposure to hazardous chemicals while in manufacturing environment
  • Identify potential hazards either safety or ergonomic
  • Must be able to lift/push/pull up to 30 pounds on an occasional basis

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.

About this company
37 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...