Site Validation Manager

Position Summary

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies.

We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.

We are currently recruiting for a Site Radiation Validation Manager. This is an excellent opportunity to join the business at managerial level and help us maintain and build on the excellent quality standards we commit to.

Role is primarily responsible for technical activities in the Site related to Radiation Technology.  Person in this role will be recognized as the primary subject matter expert & leader in their site with regard to Radiation Technology included dosimetry system, irradiator qualification and product qualification. 

Duties

    Customer Performance Qualification (30%)
•    Follow all technical procedures and work instructions (local and global)
•    Technical support for Customers and Sales team on PQ activities
•    Responsible for all PQ activities (e.g: prioritization)
•    Evaluate process capability of a given product before start of PQ activities and after data analysis
•    Approval of PQ protocol and plan
•    Analyze and investigate PQ data
•    Approval of PQ report
•    Report PQ KPI
•    Perform training of site team
•    Investigate any Nonconformity or deviation during PQ activities

1.2    Radiation Technical Support & Guidance (30%)
•    Responsible for correct implementation of all technical procedures and work instructions (local and global)
•    Support development of technical procedures and work instructions
•    Support Quality team during non-conformance investigation and audit
•    Responsible for radiation facility qualification (IQ, OQ)
•    Technical support to Customers and operation as required (e.g: monthly call, quarterly review)
•    Report and Investigate in case of dosimetry process deviation (PQ, Non-conformity, 

Duties - cont'd

   Technology Deployment and Innovation (10%)
•    Support AST on implementation of radiation innovation programs. These may include such things as Radiation Simulation Modelling; Facility Design; Technology selection, new calibration method etc.
•    Provide support to develop tools and mechanism to help the AST business adopt and deploy the most appropriate solution to the market needs
•    Support implementation of STERIS Culture (e.g: substainibility, Continuous Improvement, Lean)

   Management (10%)
•    Supervise site validation team (GPS, Talent review, Irewards, vacation)
•    Responsible for site validation team training
•    Facility Management review
•    Responsible for KPI report
•    Responsible to define validation department budget

    General 

•    Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the QSR and other directives; supports the directives and decisions of higher level management and accomplishes other duties as assigned.
•    Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.

•    Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.

•    Supports the Applied Sterilization Technologies business imperatives of Safety, Quality, Innovation, Sustainability and Lean and Customer Focus, by acting with integrity, treating everyone with mutual respect, exhibiting a genuine commitment to the success of all employees, and delivering satisfaction to our Customers through teamwork, innovation and continuous improvement; this will be accomplished while acting safely and is defined as "The STERIS Way."  of all employees, and delivering satisfaction to our Customers through teamwork, innovation and continuous improvement; this will be accomplished while acting safely and is defined as "The STERIS Way."

Education Degree

Required Experience

1.    Ability to demonstrate mathematical and technical competence for problem solving.
2.    Proficient in use of MS Excel, MS Word, MS PowerPoint.
3.    Able to complete statistical and data analysis using statistical tools such as MS Excel.
4.    Academic knowledge of Quality Systems and working in a regulated environment.  
5.    Academic knowledge of Good Documentation Practices (GDP)

Skills

1.    Ability to effectively read, write and verbally communicate in English. 
2.    Ability to work under general direction of a supervisor or senior team member. 
3.    Ability to work well with others.
4.    Above average organizing, analyzing and math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
5.    Ability to adapt to changing duties and responsibilities.
6.    Normal hearing range sufficient to hear alarms, bells, horns, etc.