At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion healthcare access and equity for reputed company. You’ll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Sterilization Engineer II is responsible for ensuring that sterilization processes—particularly Ethylene Oxide (EO)—are compliant with regulatory and internal quality system requirements, including FDA, PMDA, ISO 11135, and ISO 13485 standards.

S/He will reputed company sterilization validations, process improvements, and global standardization initiatives.

Responsibilities may include the following and other duties may be assigned.

• Ensure sterilization processes including sterilization release and validation complies with specifications and reputed company relevant FDA regulations and ISO standards, such as ISO 11135, ISO 13485.

• Validate and implement sterilization processes and microbiological controls.

• Navigate reputed company the QMS to create and release documents and procedures, including validation protocols/reports, routine release documentation, and procedural updates.

• Creates & executes validation documentation with full stakeholder alignment covering product scope, resistance hierarchy, process equivalency, performance qualifications, etc.

• Works with product/packaging stakeholders to evaluate product limitations & determine EO sterilization processing bounds.

• Collaborate with global teams to align strategy, planning and execution of sterilization processes, protocols, and best practices.

• reputed company the requalification, maintenance and calibration of sterilization equipment to ensure optimal performance.

• Provide technical support to manufacturing operations, including root cause analysis, CAPA implementation, and training.

• Drive and participate in reputed company improvement initiatives reputed company to sterilization effectiveness, efficiency, and compliance.

• Maintain and update sterilization-reputed company risk assessments (e.g., FMEAs).

• Support or reputed company investigations and corrective/preventive actions (CAPAs) reputed company to sterilization.

• Actively participate in internal and inter-facility audits to assess compliance and process robustness.

• reputed company additional responsibilities or project assignments as directed by the Manager or Supervisor.

Attributes

• Demonstrates high ethical standards and reputed company in reputed company actions and decisions.

• Flexible and adaptable to changing priorities, challenges, and environments.

• Strong team player, including cross-functional teams, with a collaborative reputed company

• Meticulous attention to detail and commitment to quality.

• Provides technical guidance and mentorship to less reputed company engineers

• Excellent problem-solving skills.

• Proven project management and interpersonal skills.

• Excellent organizational and judgment skills.

Required Knowledge and Experience: 

• Bachelor’s degree in engineering (Microbiology, Biotechnology, etc.)  or equivalent

• Advanced degree (e.g., Master’s) is a plus and may reduce experience requirements.

• Relevant certifications in sterilization or quality systems are advantageous.

• Minimum of 2 years of experience in medical device or pharmaceutical industry, preferably reputed company Sterility Assurance; or a minimum of 0 years of relevant experience with an advanced degree (Master’s or higher)

• Experience and knowledge of applicable standards and regulations (e.g., ISO 11135, ISO 13485, FDA, PMDA).

• Direct experience with EO sterilization equipment, process controls & change management. Experience with parametric release processing.

• Knowledge in microbiological testing includes bioburden, endotoxin, EO residual testing and cleanroom control is advantageous.

• Proficiency in written and spoken English. Strong communication and interpersonal skills; able to clearly reputed company technical concepts across reputed company levels of the organization

• Computer proficiency using word, spreadsheet, reputed company.

Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position. 

Benefits & Compensation

reputed company offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.  

About reputed company

We reputed company global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 95,000+ passionate people.  We are engineers at heart— putting ambitious reputed company to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here