Regional Validation Engineer

Homebased out of a Sterigenics facility, the Regional Validation Engineer will report to the Director of Validations. This role will be responsible for helping to ensure the validation procedures and regulatory requirements are met and maintained for the America's region Sterigenics Ethylene Oxide (EO) facilities and its customers. They will also provide management with information and data on all key aspects of each customer's validation project within the region, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory, EHS, Quality, Engineering and other Sterigenics' facilities, as well as customers and regulatory personnel.

Duties and Responsibilities

• Assist facilities on site/remotely in project planning and execution of facility/EAS projects to meet turn time.
• Mentor and train current and existing validation personnel in conjunction with their direct managers.
• Interface with Director of Validations to strategically plan and prioritize new and existing projects.
• Perform Root Cause Analysis / Kaizen events with facilities to promote continuous improvement.
• Writes validation protocols and final reports for the facility/EAS.
• Reviews and approves customer or consultant supplied validation or test protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
• Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
• Scheduling the project runs, ancillary resources, lab testing and sample handling.
• Cycle programming and preparation of necessary process documents and safety assessments.
• Data collection and analysis of temperature and humidity data.
• Assuring proper handling, storage and shipping of bioburden, LAL, biological indicator, or residual samples.
• Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
• Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment.
• Maintains the quality and integrity of information required for validation records.
• Liaison for facility/EAS and customer activities by responding to customers' inquiries whether directly or through Quality Assurance, Customer Service Unit or Sales, to ensure prompt and accurate communication related to technical and validation issues.
• May manage/supervise the region's validation personnel.
  Performs other duties as required to support the overall regional facility operation and quality system.

Supervision Given

May supervise/guide the validation departments within the region.

Education Required

Minimum BA or BS in a science related field (or international equivalent).

Experience and Skills Required

• Four (4) to six (6) years' experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required.
• Direct experience in sterility assurance or products sterilization required.
• Must have experience in writing and executing validation protocols.
• Customer service and project management experience desired.
• ISO 9000 experience a plus.
• Excellent written and verbal communication skills.
• Strong computer skills.
• Forklift driving experience desired.
• Must be able to lift a maximum of 50 lbs. (23kg) and perform repetitive bending and lifting motions over a period of time.
  Must be able to work a flexible schedule including weekends, holidays (if necessary).

Special Requirements

• Position will require travel to other sites (may not only be within their region) – up to 50% annually.
• Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
• Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable.
• Knowledge and experience working with the FDA and/or international requirements for medical devices is essential.
• Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
• Experience with a company using EO sterilization of products is desirable.
• Experience in document control to satisfy all ISO 13485 and FDA (or international equivalent) Quality System requirements.
• Must be medically approved for respirator use (EO).
  Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).

Training Required

Must complete all required training for a "Validation Engineer" outlined in the training manual and internal "Validation Engineer" certification.

Benefits

Sotera Health offers a competitive benefits package that includes:

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
  Employee Assistance Program (EAP)

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor