Scientist I - Validations

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.

• Supportthe conduct of scientific studies for investigation and validation purposes.
• Contributeto creating and maintaining valid sterilization processes in the medical device or pharmaceutical industry that comply to FDA regulations, ISO, AAMI, and ASTM standards.
• Actas liaison between Customer and the facility leadership during Customer driven studies.
• Assistin statistical analysis of data, such as variation analysis, specific to the modality in use.
• Contributeto successful product processing by performingtemperature/humidity sensor calibrations.
• Ensureall internal validation equipment is calibrated per procedure requirements and coordinates calibrations with external vendors.
• Ensureprocesses are maintained in a validated state by supporting periodic verifications and execution of revalidations or re-qualifications following changes.
• Providecritical 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.
• Workwith Customers during Customer driven studies to coordinate handling of material resources for use in studies, such as dunnage loads and remote sensor availability.
• Contributeto 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.
• Maintaina 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.
• Protectcompany confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Exhibita 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.

• 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.
• Adaptableto changing duties and responsibilities.
• Normal hearing range sufficient to hear alarms, bells, horns, etc.

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