Validation Engineer Job Details | Steris Corporation

Validation Engineer

Req ID: 45346...

Job Category: Engineering

Pulau Indah, 10, MY, 42920

Description:

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Primarly role is to cover all technical activities related to Radiation Technology in the Site. Person in this

role will be recognized as site support and tasks will include dosimetry system, irradiator qualification and

product qualification

Duties

Responsibilities (Primary activities with expected %time allocation shown)

1.1 Radiation Technical Support & Guidance (15%)

Support in implementation of all technical procedures and work instructions (local and

global)

Support Quality team during non-conformance investigation with technical input as required

Support radiation facility qualification (IQ, OQ) according to WI

Technical support to Customers as required.

Support production in special process activities (Dose Audit, Maximal dose testing)

Customer PQ

issues) to Site Radiation Validation Manager

1.2 Customer Performance Qualification (65%)

Ensure Customer PQ are performed according to WI (Protocol, Dosimeter placement,

Report)

Coordinate all PQ validation and special request activities to support the site for Customer(s),

Account Manager(s) and TechTeam.

Evaluate process capability of a given product before start of PQ activities and after data

analysis

Report and investigate any delay in PQ activities to Site Radiation Validation Manager

Report and investigate any Nonconformity or deviation during PQ activities

Support the prioritization and scheduling of product validation activities (e.g. dose mapping,

samples processing, quarterly dose audit) in collaboration with Sales, Operations

Track PQ activities at each step of the process once PQ activities has been approved by

Customer: Process of tracking PQs includes, but is not limited to, the following:

o Ensure PO is available

o Ensure Protocol is completed and approved.

o Coordinate delivery product for PQ with Customer.

o Schedule (prioritization / queue) PQ runs

o Coordinate execution of PQ runs

o Data analysis

o Final report completion

o Implementation routine processing in coordination with Plant Quality Manager

Duties - cont'd

1.3 Dosimetry System (15%)

Support dosimetry System qualification, calibration and maintenance activities (Protocol,

Treatment, Report, Verification, Cleaning) in accordance to WI

Measure dosimeters used for PQ and OQ activities in accordance with WI

Report any deviation or non-conformity to Site Radiation Validation Manager

Ensure dose measurement activities are performed according to WI (e.g.: Laboratory

environment control)

Support the site in case of equipment failure

Support the management of site dosimeter stock (Incoming inspection, storage,

consumption

1.4 Technology Deployment and Innovation (5%)

Support AST RTC, Radiation TAB and Tech Team group 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: For example, support in SPC

implementation.

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.'

Education Degree

Bachelor's Degree in Physics

Required Experience

Skills Required:
? Ability to effectively read, write and verbally communicate in English.
? Ability to work under general direction of a supervisor or senior team member.
? Ability to work well with others.
? Ability to adapt to changing duties and responsibilities.
? Normal hearing range sufficient to hear alarms, bells, horns, etc.
? Ability to demonstrate mathematical and technical competence for problem solving.
? Proficient in use of MS Excel, MS Word
? Academic knowledge of Quality Systems and working in a regulated environment.
? Academic knowledge of Good Documentation Practices (GDP)

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.

Req ID: 45346

Job Category: Engineering

Pulau Indah, 10, MY, 42920

STERIS Sustainability (https://www.steris.com/sustainability)

Life at STERIS (https://careers.steris.com/content/Life-at-STERIS/?locale=en_US

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