Valeant Pharmaceuticals

Sr. Sterilization Validation Engineer

US-FL-Tampa
Job ID
8581
Category
Operations
Pos. Type
Full Time

Overview

Validation of Sterilization processes and equipment including moist heat, dry heat, gamma, and ethylene oxide associated with the manufacture of pharmaceutical or medical devices to assure compliance with cGMP’s, FDA’s and BLP’s guidelines.  Job assignments are to be completed without a considerable amount of supervision or coaching.

 

In addition, Validation of manufacturing equipment, facilities, utilities and computerized systems is highly desirable.

Responsibilities

  1. Provide NC and CAPA support for NCs involving sterilization issues as needed. 
  2. Aides in trouble shooting/impact assessment for atypical conditions during sterilization runs/validations.
  3. Writing and execution/coordination of sterilization protocol testing and the respective final report. 
  4. Coordination of Sterilization qualification and requalification activities with sterilization vendors.  This includes the following            routine activities:  quarterly dose audits, dose mapping studies         following packaging configuration or source changes, and annual         EO revelation studies.
  5. Coordinate testing of   qualification and requalification activities (bio-burden, sterility, residual testing). 
  6. Update S-Specifications, and API packaging SOP as a result of the Sterilization qualification and requalification outcomes.  Update      vendor specifications/paperwork  for new components or upon        changes to the reference dose range (Gamma only).
  7. Provide guidance to the site as well as R&D for new API and component configurations/materials. 
  8. All other duties as assigned.

9.         Develop sound scientific rationale/strategy for validation of new or             modified cGMP equipment and processes.

Qualifications

Experience in one or all of the following types of validation desired: Sterilization processes including moist heat, dry heat, gamma, and ethylene oxide. Strong Project Management, organizational, analytical, computer, writing and communication skills.  Knowledge of aseptic processing highly desired. Excellent logical/mechanical aptitude desired.  Knowledge of cGMP regulations and latest validation guidelines.  Able to handle multiple priorities in a fast-paced environment. Able to work extended/odd hours around manufacturing schedule required.

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