Job Title: Scientist I - Validations
Coon Rapids, MN, US, 55433
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.
Position 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. 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.
Duties
Supports the conduct of scientific studies for investigation and validation purposes.
Contributes to creating and maintaining valid sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO, AAMI, and ASTM standards.
Acts as liaison between Customer and the facility leadership during Customer driven studies.
Assists in statistical analysis of data, such as variation analysis, specific to the modality in use.
Contributes to successful product processing by performing temperature/humidity sensor calibrations.
Ensures all internal validation equipment is calibrated per procedure requirements and coordinates calibrations with external vendors.
Ensures processes are maintained in a validated state by supporting periodic verifications and execution of revalidations or re-qualifications following changes.
Provides 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.
Works with Customers during Customer driven studies to coordinate handling of material resources for use in studies, such as dunnage loads and remote sensor availability.
Contributes 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.
Maintains 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.
Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
Exhibits 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.
Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Required Experience
1. 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.
2. Ability to demonstrate mathematical and technical competence for problem solving.
3. Proficient in use of MS Excel, MS Word, MS PowerPoint.
4. Able to complete statistical and data analysis using statistical tools such as MS Excel.
5. Academic knowledge of Quality Systems and working in a regulated environment.
6. Academic knowledge of Good Documentation Practices (GDP)
Skills
1. Ability to effectively read, write and verbally communicate.
2. Ability to work under general direction of a supervisor or senior team member.
3. Ability to work well with others.
4. 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.
5. Ability to adapt to changing duties and responsibilities.
6. Normal hearing range sufficient to hear alarms, bells, horns, etc.
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.
Coon Rapids, MN, US, 55433
Nearest Major Market: Minneapolis
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Pharmaceutical, Infection Control, Facilities, Chemistry, Medical Device, Science, Healthcare, Operations