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Validation Manager I

1 month ago

Allentown, Pennsylvania, United States Sharp Services Full time
Job Description

Job Title: Validation Manager I

Job Summary:

Sharp Services is seeking a highly skilled Validation Manager I to join our team. The successful candidate will be responsible for supervising validation staff and coordinating validation activities at designated sites.

Key Responsibilities:

  • Supervise validation staff and coordinate validation activities at designated sites
  • Design, schedule, prepare, execute, and complete assigned validation projects
  • Develop and document product master validation plans
  • Coordinate preparation and execution of validation protocols and reports
  • Represent the validation function in the review and approval of change controls involving equipment and processes
  • Develop validation requirements for projects related to new equipment, processes, and facilities
  • Supervise the execution and summarization of validation activities at designated Sharp facilities
  • Develop staff to support smooth succession and compliance with all FDA requirements
  • Participate in customer or regulatory audits at Sharp facilities as required
  • Support the investigation of consumer complaints specific to related areas

Requirements:

  • Bachelor's degree in a technical discipline (BS/BA) from a four-year college or university preferred
  • Five to ten years related experience and/or training
  • Independent certification of advanced quality skills and practices
  • Broad knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents
  • Familiarity with quality engineering practices in manufacturing operations
  • Knowledge of basic engineering principles and practices, equipment automation controls, etc.

Working Conditions:

The employee is normally required to sit at a desk or periodically go onto the shop floor and to work in close proximity to packaging equipment. Approximately 10 percent travel between Sharp sites and to off-site assignments.