Sterilization Packaging Specialist

Mentor Technical Group; South Carolina; On-site; USD 80,000 - 110,000; Full time

Job summary

Mentor Technical Group is seeking a Sterilization Packaging Specialist to support packaging and sterilization processes in a regulated manufacturing environment. This role ensures systems meet regulatory requirements and maintain product integrity and safety.

You will develop and validate sterilization and packaging processes, review validation protocols, collaborate with Quality, Manufacturing and R&D, and support audits, change controls, and technical documentation.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Experience in sterilization processes (EO, Gamma, Steam) and packaging validation in the pharmaceutical or medical device industry.
• Strong knowledge of cGMP, FDA regulations, and ISO standards (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.

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.

Skills

Sterilization processes

Packaging validation

Regulatory knowledge

Documentation skills

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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.

With offices in Caguas, Puerto Rico, and Boston, USA, MTG serves clients across the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America, delivering high-quality solutions across the life sciences sector.

Position Overview

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.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.