Validation Specialist II

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Job Summary:
Responsible for validations and equipment, facility, and system (EFS) qualifications.

Ensure the annual requalification and validations described in the VMP are scheduled and performed on time.

This is done by working with internal staff to ensure all barriers with regards to validations are identified and removed, as well as developing and managing relationships with lab staff through continual communication.
Mentor staff and perform basic training on validated instrumentation and processes.
Review non-routine repairs for potential revalidation.

Assess new equipment for qualification.

Assign open expiry for incoming chemicals, reagents, and assist with the quality assessment of incoming supplies.

Essential Duties:
Validations:


* 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 collaborates with and across teams to ensure timely


* completion of assigned projects.


* May travel to complete qualifications at internal or external labs.


* Collaborates with and across teams to resolve complex issues.

Quality Control:


* Control Charting as needed.


* Review of non-routine repairs.


* Assess new equipment for qualification.


* Provide quality oversight of new supplies ordering.

Training


* Mentor and train staff as appropriate.


* Cross train in other QC-Validation team functions.


* Cross train in use of lab equipment as necessary.

Professional Development:


* Complete required training in a timely manner (includes MasterControl, live company trainings, New Employee Orientation, etc.)

Regulatory Compliance:


* Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).


* Know and follow company policies and procedures.


* Complete required training on time.

Professionalism


* Attend work regularly and reliably.
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