Senior Specialist, Aseptic Process Solutions
Merck · De Soto, KS · 1 mo ago
Management$117k–$184k/yrFull-time
About the role
Join Us in Shaping the Future of Animal Health
Our company's Animal Health division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date.
Responsibilities
- Support operational leadership in the development, implementation, and maintenance of aseptic practices within dedicated sites of our Company's Animal Health network
- Establish and direct deployment/implementation of proactive measures across our Company's 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
Requirements
- 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 include media simulation, smoke studies, Clean Room Qualification, Steam-in-Place validation, Environmental Monitoring, etc.
- Possess analytical, problem solving, and technical writing skills required to provide quality, microbiological and technical expertise for sterility assurance investigations related to media challenge/sterility failures, product deviations, and contamination control.
- Must also possess interpersonal skills: coaching and development, performance management, motivation and effective communication.
- Able and experienced to think at a global level and be able to 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
- Contamination Control
- Detail-Oriented
- Environmental Monitoring
- Manufacturing
- Manufacturing Quality Control
- Microbiology
- Process Improvements
- Project Planning