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Sotera Health Company · 4 months ago

Associate Validation Engineer

5725 W Harold Gatty Dr, Salt Lake City, UT, 84116, US

Full-time

Onsite

Mid Level

4+ years exp

Sotera Health Company is a leader in providing innovative solutions for the healthcare industry, and they are seeking an Associate Validation Engineer. The role involves coordinating customer validation activities, writing protocols, and ensuring compliance with regulatory standards while supporting overall plant operations.

BiotechnologyHealth CareMedical Device

H1B Sponsor Likely

Responsibilities

Plans, organizes, and coordinates customer validation activities at the facility

Writes validation protocols and final reports supplied by the facility

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

Microbiological samples

Data collection and analysis of temperature and humidity probe data

Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory

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

Responsible for annual equipment re-commissioning (sterilization and laboratory)

Update validation status in the relevant systems

May be required to assist with corrective action and validation process improvement activities. Performs other duties as required to support the overall plant operation and quality system

Qualification

Validation protocolsFDA regulationsGMP/GLP knowledgeSterility assuranceISO 9000 experienceDocument controlCustomer serviceComputer skillsForklift drivingProject managementCommunication

Required

Minimum BA or BS in a science related field (or international equivalent) and/or 4-6 years equivalent experience

Two (2) to four (4) years of 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 a plus but not required

Experience in writing and executing validation protocols preferred

Customer service and project management experience desired

ISO 9000 experience a plus

Excellent written and verbal communication skills

Strong computer skills

Must be able to lift a minimum 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)

Must be able to travel 10-20% to various locations as needed

Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements

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 in document control to satisfy all ISO 9000 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)

Must complete all required training for validation internal certification

Preferred

Experience in writing and executing validation protocols preferred

Forklift driving experience preferred, however internal training will be given

Benefits

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)

Company

Sotera Health Company

Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena.

Founded in 2017

Broadview Heights, Ohio, USA

1001-5000 employees

https://soterahealth.com

H1B Sponsorship

Sotera Health Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (1)