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Sr. Specialist, Aseptic Process Solutions

Merck
5 days ago
Remote friendly (De Soto, KS)
United States
$114,700 - $180,500 USD yearly
Operations

Role Summary

Sr. Specialist, Aseptic Process Solutions in the Animal Health network, based in De Soto, Kansas. Support the successful implementation and sustainability of the Aseptic Process Support Program across Animal Health sites. Raise aseptic robustness and help develop and enhance sterile standards across operations.

Responsibilities

  • Support operational leadership in the development, implementation, and maintenance of aseptic practices within dedicated sites of the Animal Health network
  • Establish and direct deployment/implementation of proactive measures across Animal Health Sterile facilities to enhance and sustain aseptic programs
  • Solve problems on the shop floor with urgency and ownership
  • Provide Media Simulation and Sterility Failures Investigation support for selected sites
  • Provide hands-on support in implementation of Aseptic Processing Policies and Standards

Qualifications

  • Associate’s degree in Microbiology, Process Engineering, Quality/Process Management or related discipline and 8 years of experience in the Manufacturing Industry working in sterile environments with background in microbiology and sterile process equipment design
  • Or Bachelor’s degree in Microbiology, Process Engineering, Quality/Process Management or related discipline and 5 years of experience in the Manufacturing Industry working in sterile environments with background in microbiology and sterile process equipment design
  • Hands-on experience in the development of aseptic programs including media simulation, smoke studies, Clean Room Qualification, Steam-in-Place validation, Environmental Monitoring, etc.
  • Analytical, problem solving, and technical writing skills required to provide quality, microbiological and technical expertise for sterility assurance investigations related to media challenges/sterility failures, product deviations, and contamination control; strong interpersonal skills including coaching and development, performance management, motivation and effective communication
  • Ability and experience to think at a global level and develop risk assessments, action plans, and position papers
  • Hands-on experience in the development and enhancement of sterile standards within the Animal Health environment

Skills

  • Aseptic Operations
  • Aseptic Processing
  • Aseptic Technique
  • Critical Thinking
  • Equipment Designing
  • Manufacturing
  • Microbiology
  • Problem Solving
  • Technical Writing

Education

  • Associate’s degree in Microbiology, Process Engineering, Quality/Process Management or related discipline
  • Bachelor’s degree in Microbiology, Process Engineering, Quality/Process Management or related discipline

Additional Requirements

  • Travel: 25%