Job Title:  Validation Technician I

Position Summary

Validation Technicians are responsible for the entire production validation process at their modalities.  This includes Customer qualification of products and validation of the sterilization process in accordance with established procedures. They work closely with the TechTeam or the Customer to assure the protocols are executed with care and are documented properly.  Generates accurate records including protocols and reports evidencing completion of these activities.

Duties

Essential Job Functions
Operational Excellence (100%)

1.    Maintains proper function of data collection devices used in validations and qualifications per procedure requirements.

2.    Executes instrument calibrations per established procedures.

3.    Executes Customer validations for routine production processing and those for dose audits or engineering studies.  Generates study documentation.  Supports processing of Customer experimental samples including dose audits. 

4.    Executes product validations as scheduled.

5.    Operates processing vessels, irradiators and/or electron beam equipment on Customer product as applicable.

6.    Ensures processes are maintained in a validated state by executing revalidations following changes as well as performing periodic verifications.

7.    Investigates unexpected test results and proposes solutions to process deviations and Customer complaints.  Supports updates to procedures related to their responsibilities.

8.    As required by modality generate protocol, analyze, format data and reports.

9.    Contributes to safe and accurate processing by notifying Manager of any event, item or documentation that may have a concern in regard to regulatory or specification compliance, Customer product quality, or employee safety.

10.    Assists in the performance and adherence to ISO requirements. 

11.    Strives for continuous improvement by analyzing new or alternative ways to improve operations; incorporates recommendations into analysis; responds to audit activities in a constructive manner and uses findings to improve operations where possible.

12.    Contributes in a team effort by performing in accordance to all STERIS policies, GMP, Lean principles and other directives; supports the directives and decisions of higher-level management and performs other duties as assigned. 
 

Duties - cont'd

Education Degree

Required Experience

1.    A minimum of one (1) year of experience in sterilization or related industry.
2.    Pass company Operator training program, preferred. 
3.    Ability to effectively write and verbally communicate 
4.    Ability to work independently under general guidelines and supervision. 
5.    Effective interpersonal skills as demonstrated through prior management experience.
6.    Requires ability to navigate through defined computer screens.
7.    Above average organizing and analyzing skills and Level 2 math skills (four basic arithmetic functions in all units of measurement, decimals ratios, rates, percentages) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
8.    Ability to adapt to changing duties and responsibilities.
9.    Normal hearing range sufficient to hear alarms, bells, horns, etc.
 

Preferred Experience

• Associates Degree

Skills

Preferred candidates will be able to communicate in English and Spanish.