Coon Rapids, MN, US
5 days ago
Scientist I - Validations

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Summary:

Responsible for the activities related to the coordination of validation of sterilization processes across STERIS operating facilities. This will NOT be a laboratory-based position. You will be based in a plant environment working for a large scale contract Sterilizer preparing validation pallets with samples and sensors. Your time will be a combination of working in operational areas, reviewing data and team meetings.

 

Activities include calibration of data collection systems, such as maintaining dosimeters and dosimetry equipment, measurement of dosimeters for report generation; operation, and data collection related to portable temperature/humidity sensors; coordinating with external laboratories for equipment calibrations and maintenance; coordinating with Customers for test sample processing and requalification studies; coordination and proper handling of product samples for transfer to outside laboratories for testing; and other routine tasks as directed by the immediate supervisor or manager. 

What You'll do as a Scientist I - Validations: Support the conduct of scientific studies for investigation and validation purposes.  Contribute to creating and maintaining valid sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO, AAMI, and ASTM standards. Act as liaison between Customer and the facility leadership during Customer driven studies.  Assist in statistical analysis of data, such as variation analysis, specific to the modality in use. Contribute to successful product processing by performing temperature/humidity sensor calibrations. Ensure all internal validation equipment is calibrated per procedure requirements and coordinates calibrations with external vendors.   Ensure processes are maintained in a validated state by supporting periodic verifications and execution of revalidations or re-qualifications following changes. Provide critical support for Customer turnkey validation service(s) by executing and assisting in the management of the validation activities, such as coordination of samples receipt, placement, retrieval, storage and shipment, generation and maintenance of documentation for study activities.  Work with Customers during Customer driven studies to coordinate handling of material resources for use in studies, such as dunnage loads and remote sensor availability.  Contribute to safe and accurate processing by notifying management of any event, item or documentation that may have a concern in regard to regulatory or specification compliance, Customer product quality, or employee safety. Maintain a safe work environment by attending safety meetings with local facility, completing safety rounds, and tracking all hazardous materials as contained in the Safety Data Sheets. Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized. Exhibit a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency. The Experience, Skills, and Abilities Needed: Scientist I will be entry-level personnel with a B.S. degree in a technical discipline (engineering, physics, biology, chemistry, etc.) that will strive for mastery of all above-listed essential job functions. Ability to demonstrate mathematical and technical competence for problem solving. Proficient in use of MS Excel, MS Word, MS PowerPoint. Able to complete statistical and data analysis using statistical tools such as MS Excel. Academic knowledge of Quality Systems and working in a regulated environment.   Academic knowledge of Good Documentation Practices (GDP) Ability to effectively read, write and verbally communicate .  Work under general direction of a supervisor or senior team member.  Work well with others. Above average organizing, analyzing and Level 4 math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail. Adaptable to changing duties and responsibilities. Normal hearing range sufficient to hear alarms, bells, horns, etc.    What STERIS Offers:

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. 

 

Here is just a brief overview of what we offer:

Market competitive pay Extensive Paid Time Off and added Holidays Excellent Healthcare, Dental, and Vision benefits Long/Short Term Disability coverage 401(k) with a company match Maternity & Parental Leave Additional add-on benefits/discounts for programs such as Pet Insurance Tuition Reimbursement and continued education programs Excellent opportunities for advancement in a stable long-term career

 

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

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