Sterilization Program Manager

Integrated Resources, Inc

Remote, CA(remote)

JOB DETAILS
SKILLS
Agile Programming Methodologies, Biomedical Engineering, Change Control, Change Management, Chemical Engineering, Continuous Improvement, Cross-Functional, Customer Support/Service, Establish Priorities, Failure Mode and Effects Analysis (FMEA), Investment Management, Leadership, Maintain Compliance, Metrics, Microbiology, Microsoft Office, Microsoft Project, Operations Management, Performance Metrics, Process Improvement, Product Testing, Product/Service Launch, Project Management Professional (PMP), Project Management Software, Project Planning, Project Schedule, Project/Program Coordination, Project/Program Management, Regulations, Regulatory Compliance, Research & Development (R&D), Risk, Risk Management Framework (RMF), Sterilization, Supply Chain Operations, Vendor/Supplier Planning
LOCATION
Remote, CA(remote)
POSTED
24 days ago
Title: Sterilization Program Manager
Location: 100% Remote (Northridge CA)
Duration: 12 Months+ Possible Extension


Manager Notes:
Support management of concurrent sterilization projects.

Job Description:
  • Lead and manage the full sterilization project portfolio, including new product launches, validations, revalidations, and process improvements
  • Develop and maintain integrated project plans, timelines, resource maps, and risk registers -Drive cross-functional alignment across R&D, Quality, Regulatory, Operations, and Supply Chain -Facilitate portfolio-level prioritization and trade-off decisions with senior leadership.
  • Establish and report on KPIs, milestones, and program health metrics Provide Technical Oversite.
  • Serve as subject matter expert (SME) for EO sterilization processes including supporting microbiological/chemical methods.
  • Ensure compliance with international regulations -Support other SMEs with technical challenges as required Sterilization & Service Suppliers.
  • Coordinate with internal cross-functional partners to support relationships with contract sterilizers and laboratory service providers -Coordinate project scheduling with service suppliers based on prioritization Stakeholder & Change Management.
  • Communicate program status, risks, and decisions clearly to executive and cross-functional stakeholders -Lead change control activities for sterilization process changes -Drive a culture of continuous improvement and sterilization process optimization
Required Skills:
  • Bachelor's degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related field Deep knowledge of sterilization validation lifecycle with 3+ years experience with EO sterilization validation and/or operations Program Management skills: -Proficiency in project management tools (MS Project, Smartsheet, or similar)
  • Strong portfolio management and resource planning capabilities
  • Experience with risk management frameworks (FMEA, risk registers) -PMP or equivalent certification is a plus.
Technical Skills:
  • MS Office, MS Project/Smartsheet, Agile

About the Company

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Integrated Resources, Inc