Manager, Validation: Sterility Assurance - Cook Pharmica
Cook Medical - Bloomington, IN

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· To establish validation policy/strategy to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation and to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations.


Essential Functions:
  • Manage multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes
  • Establish philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures
  • Manage the activities of direct reports to accomplish scope of work of validation department
  • Manage protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation
  • Review and approve facility equipment and soft ware changes, evaluate and determine required validation testing
  • Coordinate contract commissioning and validation services including contract review and approval
  • Oversee the implementation of laboratory validation requirements
  • Coordinate the development, execution and approval Enhanced Design Reviews and Risk Assessments
  • Reviews processes for application of Process Analytical Technology (PAT)
  • Manage and monitor on-time closure of investigations and corrective action/preventive action items
  • Determine training requirements for commissioning and validation for validation department, contractors, vendors and consultants and supervise the execution of required training

Additional Responsibilities:
  • Provide reports to Quality Management on a regular basis
  • Participate in department training and safety programs
  • Serve as company representative during internal and external inspections for areas of responsibility
  • Develop staff to maximize contributions to team and company

· Execute purchase orders up to a limit of $2000
· Identify and report possible preventive and corrective actions
· Identify and report possible exceptions to standard operating procedures
· Identify and report safety and environmental hazards
· Coach, counsel and discipline direct reports as appropriate


· Bachelor’s degree in Life Sciences, Engineering or equivalent experience relevant
· Minimum of 8+ years of experience in validation/qualification, Validation Master Plans, protocols, final reports, as well as multiple areas of validation activities in the biotechnology pharmaceutical industry
· Minimum 5 years supervisory or leadership experience
· Required to sign a confidentiality and a non-compete agreement

· Possess excellent supervisory, interpersonal, leadership, project management skills
· Must possess confidence and be able to communicate with all levels of personnel and regulatory authorities
· Demonstrated ability to build, develop, lead and manage staff
· Strong understanding of Equipment, Facilities, Cleaning and Process Validation of mammalian cell culture-based biopharmaceutical and parenteral manufacturing and parenteral secondary packaging operations
· Ability to prepare cost estimates, timelines and project schedules using computer applications
· Excellent oral and written communication skills and computer literacy skills
· Ability to coordinate efforts of various departments and contractors
· Excellent technical writing skills
· Ability to work in team environment

· Responsible for employment decisions
· Responsible for completing assigned tasks by due dates
· Responsible for the initiating, completing, reviewing and approving 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 sitting for majority of the day
  • Must be able to lift/push/pull up to 30 pounds on an occasional basis
  • 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

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.