What are the responsibilities and job description for the Sterilization Engineer position at United Pharma Technologies Inc?
Product Development Specialist/Sterilization Engineer – Medical Devices
Location: Onsite – Pennsylvania (PA)
We are seeking an experienced Product Development Specialist to support the development, validation, and commercialization of medical device products. The ideal candidate will have strong expertise in medical device sterilization, radiation sterilization, radiation dose mapping, and cleaning validation, along with experience collaborating with external manufacturers and suppliers
Key Responsibilities
- Lead and support sterilization validation activities for medical device products.
- Develop, execute, and analyze radiation sterilization and radiation dose mapping studies in accordance with ISO 11137 requirements.
- Plan, execute, and document cleaning validation protocols and reports to ensure regulatory compliance.
- Collaborate with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams throughout the product development lifecycle.
- Work closely with contract manufacturers, sterilization vendors, and suppliers to support process development, validation, and continuous improvement initiatives.
- Evaluate product and process changes for impact on sterilization, cleaning validation, and product quality.
- Author and review technical documentation, validation protocols, reports, risk assessments, and change controls.
- Support audits, investigations, CAPAs, and regulatory compliance activities.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
- 5–10 years of experience in the medical device industry.
- Strong hands-on experience with medical device sterilization validation.
- Expertise in radiation sterilization and radiation dose mapping.
- Experience developing and executing cleaning validation programs.
- Experience working with external manufacturing partners, suppliers, and sterilization service providers.
- Knowledge of FDA regulations, ISO 13485, ISO 11137, and GMP requirements.
- Strong technical writing, problem-solving, and cross-functional communication skills.