EtO Sterilization Specialist — Remote Contract

Stark Pharma Solutions Inc; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Sterilization Consultant with deep Ethylene Oxide (EtO) sterilization expertise to support a medical device organization.

The role is primarily technical with some project coordination, focusing on sterilization validation, supplier transitions, and ensuring compliance across multiple product lines. The consultant will serve as the technical SME for EtO sterilization processes, support evaluation and transition of services to new providers, and

Qualifications

• Extensive experience as a Sterilization SME in the Medical Device industry.
• Strong expertise in Ethylene Oxide (EtO) sterilization.
• Hands-on experience with sterilization validation and lifecycle management.
• Knowledge of applicable sterilization regulations and industry standards (ISO 11135 preferred).
• Experience working with contract sterilization suppliers and validation documentation.
• Strong communication and project coordination skills.

Responsibilities

• Serve as the technical SME for EtO sterilization processes and validation activities.
• Support evaluation and transition of sterilization services to new contract sterilization providers.
• Assess existing sterilization processes and recommend improvements where needed.
• Lead and support sterilization validation activities to ensure regulatory compliance.
• Review sterilization protocols, reports, and supporting documentation.
• Collaborate with Quality, Regulatory, Manufacturing, and external sterilization vendors.
• Provide technical guidance on sterilization standards, risk assessments, and process optimization.
• Support project planning, timelines, and supplier coordination throughout the transition.

Skills

Sterilization SME

EtO sterilization

Sterilization validation

Lifecycle management

Regulatory compliance

Risk assessments

Project coordination

Communication skills

Job description

Stark Pharma Solutions Inc. is seeking a Sterilization Consultant with deep Ethylene Oxide (EtO) sterilization expertise to support a medical device organization.

The role is primarily technical with some project coordination, focusing on sterilization validation, supplier transitions, and ensuring compliance across multiple product lines. The consultant will serve as the technical SME for EtO sterilization processes, support evaluation and transition of services to new providers, and