Open role
[Remote] Sterilization Program Manager
Note: The job is a remote job and is open to candidates in USA. LanceSoft, Inc. is seeking a Sterilization Program Manager to lead and manage the full sterilization project portfolio, including new product launches and process improvements. The role involves developing project plans, driving cross-functional alignment, and ensuring compliance with international regulations.
Responsibilities
- 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
- 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
- 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
- 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
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
- 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
Company Overview
Company H1B Sponsorship