Sterilization Packaging Specialist

Mentor Technical Group

About The Position

We are seeking a Sterilization Packaging Specialist to support packaging and sterilization processes within a regulated manufacturing environment. This role is critical in ensuring that packaging systems and sterilization methods meet regulatory requirements, maintain product integrity, and support overall product quality and safety.

Requirements

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.

Nice To Haves

Experience supporting medical device or combination product packaging.
Knowledge of sterile barrier systems and package integrity testing methods.
Experience with change control systems and regulatory impact assessments.
Bilingual proficiency in English and Spanish is preferred.

Responsibilities

Support the development, validation, and implementation of sterilization and packaging processes.
Ensure packaging systems maintain sterility and meet product protection requirements throughout the product lifecycle.
Review and approve sterilization validation protocols and reports (e.g., EO, gamma, steam).
Collaborate with cross-functional teams including Quality, Manufacturing, and R&D to support new product introductions and process improvements.
Evaluate packaging materials, configurations, and sealing processes to ensure compliance with regulatory and industry standards.
Support risk assessments related to packaging and sterilization processes.
Review and maintain technical documentation, including SOPs, specifications, and validation records.
Assist in investigations related to sterilization failures, packaging defects, and non-conformances.
Ensure compliance with cGMP, FDA, and ISO standards applicable to sterilization and packaging (e.g., ISO 11135, ISO 11607).
Support change control activities related to packaging and sterilization systems.
Participate in audits and regulatory inspections, providing subject matter expertise as needed.