Sterilization Process Engineer

Sterilization Process Engineer#25-67292

$30.46-$32.80 per hour

Durham, NC

All On-site

Job Description

Our Client, a Business Manufacturer and Supply company, is looking for a Sterilization Process Engineer for their Durham, NC location.

Responsibilities:

Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations

Work with operations to gather support needed, information, and provide updates on process status

Quickly respond to production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations

Work with operations to further develop SPC/SQC for process discipline and control (PD/PC)

Provides technical leadership in assigned processes and escalate issues appropriately

Act to continuously improve and expand the core process capabilities

Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications

Responsible for providing technical expertise and strategic direction for sterilization

Supporting and executing activities related to development, validation, routine sterilization and requalification activities

Lead and work collaboratively across project teams as assigned, which may include commercial product support, continuous improvement activities, innovation projects, or other activities related to sterilization

Reviewing and analyzing process data for trends and improvement areas

Monitor internal asset performance with focus to 98% uptime

Documents changes via the change control process

Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality

Occasionally must flex working schedule as required to meet business needs

Provide indirect leadership to assigned technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals

Requirements:

Minimum Bachelor's degree in engineering, material science, physics, physical science or other related science degree program

0-3 years experience in engineering or manufacturing environments

Creative/innovative problem solving

Able to collaborate across organizational boundaries and integrate solutions

Strong experimental practices and engineering problem solving; can understand fundamentals and recognize deviations and implement routine solutions

Proficient in the use of software programs such as MS Word, Excel, PowerPoint

Broad knowledge of sterilization techniques and fundamentals

Become a subject matter expert in sterilization technology

Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies

Experience within the Life Sciences or medical device industries

Medical device quality systems and sterility assurance requirements

DMAIC and/or lean manufacturing principles

Equipment and product design and validation experience

Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)

Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation

Experience working with data analysis software (JMP, Minitab, etc..)

Must have good Excel skills as well as Word and PowerPoint knowledge

Bachelor's degree is required

Plus if they have experience with radiation technology, e-beam nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies

Sterilization experience is not required

Why Should You Apply?

Health Benefits

Referral Program

Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.