Sterilization Manager (Validation)

IntePros is currently looking for a Sterilization Manager (Validation) to join one of our growing medical device manufacturing clients in the Philadelphia. The Sterilization Manager is responsible for qualification, validation, and lifecycle management of terminal sterilization equipment and processes. This includes bioburden environmental monitoring and sterility assurance strategy. The position is also responsible for utilities/facilities qualification and temperature mapping. Develops and maintains associated Validation Master Plans, Standard Operating Procedures, Work Instructions, as well as other applicable documentation.

Interacts with customers and the clients Philadelphia site to ensure that the sterilization process is validated in compliance with product requirements and applicable industry standards. Ensures that any sterility assurance strategy provides appropriate risk-mitigation in the stepwise reduction of bioburden. In charge of defining and maintaining the sterilization processing categories and the product families. SME supporting change management and maintaining the qualified/validated state of sterilization equipment and processes.

Communicates with other departments regarding validation planning and coordinates resources for protocol execution. Collaborates with the site commercial Validation Manager for any validation overlap. Assures regulatory and any applicable customer requirements are accurately incorporated into client systems and assures validation documentation adheres to cGMP requirements.

Sterilization Manager Responsibilities

• Manage Quality Management System elements necessary to ensure appropriate characterization of the sterilizing agent, development, validation, and routine monitoring and control of the terminal sterilization process.
• This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, Validation and Life Cycle Management requirements. Provides leadership and coaching in terminal sterilization of devices, bioburden control, and sterility assurance.
• Direct interface and support for strategic device sterilization accounts.
• Mentoring and/or training in technical elements of validation (e.g. Risk Analysis, MSA and DOE) and sterilization process (e.g. dose mapping, dosimeter placement, product-to-sterilizer orientation, etc.).
• Responsible for sterilization dose mapping activities for new products or changes to existing products.
• Support routine terminal sterilization operations. Responsible for the site Environmental Monitoring program.
• Responsible for the site Temperature Mapping program. Develop and maintain the client PHL Site Validation Master Plan for terminal sterilization of devices.
• Develop and maintain the client PHL Site Validation Master Plan for utilities/facilities.
• Develop, approve, and execute Validation Lifecycle Documentation.
• Support and influence change management on site: Liaison between Validation Core Team, client Business Unit Program Managers, Site Leadership Team and Client PHL Customer Programs.
• Participate in site quality management reviews and reports on Validation status. Drives continual improvement to foster a culture of quality that permeates all levels of the organization.
• Ensures compliance and regulatory readiness. Supports regulatory inspections and customer audits.
• Manage, identify, hire, and develop staff. Create and maintain employee and organizational development.
• Oversee proper training, goal setting and effective organizing and assigning of work. Support validation harmonization among sites across the client Services organization.
• Provide Validation technical expertise and guidance.
• Develop and administer budgets, schedules and performance evaluations. Knowledge of and adherence to client policies and procedures.
  
  

Required

Sterilization Manager Qualifications:

• Bachelor or Technical Equivalent Degree in Engineering, Microbiology or Science field.
• 7 years combined Quality, equipment qualification, and process validation process experience.
• 5 years of experience in terminal sterilization validation and sterility assurance with heavy emphasis in sterilization competency and validation strategy.
• 5 years of experience with medical device, combination device, or other regulated industries.
• Strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification and Validation Requirements.
• Terminal sterilization experience with Ethylene Oxide (EtO), Vaporized Hydrogen Peroxide (VHP), and/or Nitrogen Dioxide (NO2).
• Quality System Management experience.
• Process Development experience.
• Demonstrated knowledge of analytical and statistical tools (e.g. Minitab, Advanced MS Excel capabilities)
• Green Belt / Black Belt on Six Sigma Training is a plus.
• Ability to lead or participate in Root Cause Analysis and Risk Management exercises (e.g. FMEA)
  
  

Sterilization Manager Skills

• Works independently with minimal guidance.
• Usually determines own work priorities.
• Acts as a resource and mentor for colleagues with less experience
• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• Supervisory Responsibilities
• High Standard of Report Writing
  
  

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to show success in managing employees.
• Ability to demonstrate attention to detail.
• Ability to set and achieve challenging goals.