Sterilization Program Manager

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 Oversight:

• 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.

Location

Join us remotely from anywhere in California and enjoy the flexibility of working from the comfort of your home while driving impactful projects in a dynamic and innovative environment.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.