Sterilization Packaging Specialist
On-site · South Carolina, United States
Job Summary
Sterilization Packaging Specialist responsible for developing, validating, and implementing sterilization and packaging processes in a regulated manufacturing environment. Ensure packaging systems maintain sterility and protect product integrity throughout the lifecycle. Review sterilization validation protocols and reports (EO, gamma, steam) and collaborate with Quality, Manufacturing, and R&D on new product introductions and process improvements. Evaluate packaging materials, configurations, and sealing processes to ensure compliance with regulatory and industry standards; support risk assessments, maintain technical documentation (SOPs, specifications, validation records), and assist in investigations of sterilization failures and packaging defects. Ensure compliance with cGMP, FDA regulations, and ISO standards (ISO 11135, ISO 11607); support change control activities and participate in audits/regulatory inspections with subject-matter expertise.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Experience in sterilization processes (e.g., Ethylene Oxide, Gamma, Steam) and packaging validation within the pharmaceutical or medical device industry.
- Strong knowledge of cGMP, FDA regulations, and applicable ISO standards (e.g., ISO 11135, ISO 11607).
- Experience with validation processes, including IQ/OQ/PQ and risk management methodologies.
- Strong technical writing and documentation review skills.
- Ability to manage multiple projects and work in a cross-functional environment.
- Excellent analytical, problem-solving, and communication skills.
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