Validation Specialist II

Sotera Health•Salt Lake City, UT

23h•Hybrid

About The Position

The Validation Specialist II is responsible for validations and equipment, facility, and system (EFS) qualifications. This role ensures the annual requalification and validations described in the Validation Master Plan (VMP) are scheduled and performed on time. This is achieved by collaborating with internal staff to identify and remove validation barriers, and by developing and managing relationships with lab staff through continuous communication. The specialist will also mentor staff, perform basic training on validated instrumentation and processes, review non-routine repairs for potential revalidation, and assess new equipment for qualification. Additionally, the role involves assigning open expiry for incoming chemicals and reagents and assisting with the quality assessment of incoming supplies.

Requirements

Attention to detail.
Ability to follow written instructions.
Must have verbal and written communication skills.
Legible handwriting.
Customer service skills.
Project management skills.
Advanced math skills required.
Must be able to multi-task and be self-motivated.
Time management- must be able to respond to voicemails, emails, and other communications in a timely manner.
Computer skills: knowledge of Microsoft Office, email and internet usage.
Communication skills: good verbal communication a must, proficiency in writing techniques a plus.
Ability to work independently.
Regular and reliable attendance required.
A.A./A.S. and four years of applicable experience OR B.S./B.A with at least two years of applicable experience.
Microbiology or biological science strongly preferred.

Nice To Haves

M.S.
ASQ certifications
Master Trainer certification

Responsibilities

Write, execute protocols, and document test results in accordance with current standards.
Compile raw data and final report into completed binder.
Coordinate efforts to ensure VMP is maintained on time.
Review workload and coordinate strategies to utilize resources to meet on-time schedule.
Act as project owner and collaborate with and across teams to ensure timely completion of assigned projects.
May travel to complete qualifications at internal or external labs.
Collaborate with and across teams to resolve complex issues.
Control Charting as needed.
Review of non-routine repairs.
Assess new equipment for qualification.
Provide quality oversight of new supplies ordering.
Mentor and train staff as appropriate.
Cross train in other QC-Validation team functions.
Cross train in use of lab equipment as necessary.
Complete required training in a timely manner (includes MasterControl, live company trainings, New Employee Orientation, etc.).
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
Know and follow company policies and procedures.
Complete required training on time.
Attend work regularly and reliably.
Adhere to all policies and procedures.
Perform other duties as assigned.