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Phillips Medisize · 7 hours ago

Sterilization Engineer

Hudson, WI

Full-time

Hybrid

Entry, Mid Level

$80K/yr - $100K/yr

2+ years exp

Phillips Medisize, a Molex Company, is seeking a Sterilization Engineer to support their Global Technical Services Team. This role involves managing sterilization activities to maximize profitability and ensuring compliance with customer and regulatory requirements.

Health CareHealth DiagnosticsManufacturingOutsourcing

No H1B

U.S. Citizen Only

Responsibilities

Interpret and negotiate sterilization requirements to meet customer needs

Act as a sterilization resource to partner with Sales, Cost Estimators, Purchasing and Business Development on quoting and sourcing programs with packaging materials and/or sterilization services and trade show support

Set top-level project implementation deliverables and dates and manage the execution

Identify software, hardware and equipment needs for sterilization operations

Identify and monitor the supporting resources required for various stages of business implementation, on-going support of the sterilization operations and drive task-level management

Partner with Customers, Quality/Validation/Manufacturing/Project Engineers and Program Managers to successfully transition programs from development to production

Coordinate the transfer of contracted programs to Phillips-Medisize facilities

Remain up to date on the latest trends and technologies in the sterilization industry

Partner with Regulatory/Validation personnel related to Sterilization Management

Qualification

Sterilization processesValidationMedical device quality assurance21 CFR 820ISO 13485GMP practicesSterilization methodsMicrobiology knowledgePackaging validationEquipment validationSoftware validationProcess qualificationLeadership experience

Required

Bachelor's degree in Biochemistry or related engineering field

2+ years of experience in sterilization processes, validation, and/or medical device quality assurance

Strong understanding of 21 CFR 820, 21 CFR 211, ISO 13485, and GMP practices

Experience with specific sterilization methods such as ethylene oxide, gamma, steam, or vaporized hydrogen peroxide

Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship

Preferred

Knowledge of microbiology related to sterilization processes is beneficial

Experience with packaging validation and sterile barrier packaging

Experience with any of the following regulations, standards, and guidance documents for Packaging and Sterilization: IEC 60601, ISO 15223-1, ISO 20417, ISO 17665, ISO 11135, ISO 11137, ISO 17664, ISO 11607, ASTM standards for test methods

Previous leadership experience

Experience with Equipment, Software, and/or Process Validation and Qualification

2+ years packaging engineering experience

2+ years sterilization experience

Benefits

Medical

Dental

Vision

Flexible spending and health savings accounts

Life insurance

ADD

Disability

Retirement

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Company

Phillips Medisize

As a contract development and manufacturing organization (CDMO), the world’s leading pharmaceutical, medtech and in vitro diagnostic companies trust us to help them design and manufacture their products.

Founded in 1964

Hudson, Wisconsin, USA

5001-10000 employees