Sterilization Packaging Specialist

About the role

Mentor Technical Group (MTG) is a leading provider of engineering and technical solutions for FDA-regulated industries. We specialize in supporting pharmaceutical, biotechnology, and medical device companies to ensure full compliance with safety, quality, and regulatory standards.

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.

Key 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.

Qualifications & 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.

Preferred Qualifications

• 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.