Associate Director, Validation

1 week ago

Albuquerque, New Mexico, United States curiate Full time
Job Summary

The Associate Director, Validation is a key leadership role responsible for overseeing and leading validation activities across multiple areas, including equipment, facilities, processes, cleaning, computerized systems, and major projects. This role ensures that all validation activities comply with regulatory requirements and client expectations, while also contributing to the strategic direction of the validation department.

Key Responsibilities
  • Develop and continuously improve site validation program, including equipment, process, cleaning, sterilization, and CSV
  • Responsible for completing initial qualifications and requalification of facility, equipment, process, cleaning, and computer systems
  • Direct and provide quality leadership within the validation department and cross-departmental leadership and direction at Curia
  • Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance
  • Ensure validated parameters are transferred to routine manufacturing
  • Provide guidance and support for site aseptic process simulations
  • Provide compliance direction and leadership to the validation department and company-wide in establishing validation strategies based on industry best practices and regulatory expectations
  • Provide validation impact assessments for facility, utility, and equipment changes and input related to product technology transfers to the facility
  • Serve as the validation liaison and SME by providing technical reviews on new product opportunities, including new equipment and technology
  • Coordinate validation activities with section supervisors to ensure timeliness with minimal disruption to production and facility shutdown schedules
  • Direct validation process improvements and goals for Curia using current regulations and demonstrated best practices
  • Serve as the validation liaison between the site and customers or regulatory agencies during facility audits/inspections
  • Support effective and efficient continuous quality and cost improvement efforts
  • Hire, train, and develop staff and conduct performance reviews to assure highly effective, team-oriented contributors to Curia's success
  • Read/interpret SOPs to ensure compliance
  • Maintain up-to-date trainings
Requirements
  • Bachelor's degree in a scientific or relevant field
  • Minimum eight (8) years' validation or relevant work experience in the pharmaceutical products/medical devices industry, including regulatory compliance and quality
  • Minimum of two (2) years' experience in a validation leadership role
  • Relevant experience in change control and validation activities
  • Third-party contract manufacturing experience in the Pharmaceutical industry, strongly preferred
Working Environment

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities, and vibration. In addition, some positions may work with or be exposed to compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents.

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