QA Sterilization Engineer Job in Covington, GA 30015
Title :
QA Sterilization Engineer
Company :
C. R. Bard
Location :
Covington, GA 30015
Date Acquired :
7/14/2009 10:33:37 PM
QA Sterilization Engineer
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: QA Sterilization Engineer/Engineering
Job ID: 2009-3755
Standard Title: QA Sterilization Engineer
Career Level: experienced
Location/Division: Covington, GA/Bard Medical
Relocation: yes
Posted Date: 7/14/2009
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
The QA Sterilization Engineer position is located in Covington, GA at Bard Medical Division.
Summary of Position with General Responsibilities:
The QA Sterilization Engineer is responsible for directing and conducting the EO validation activities for all C.R. Bard divisions whose product is processed by Bard to include product evaluation for adoption into the sterilization program. This position also is responsible for technical studies and analysis to support the overall sterilization program and environmental monitoring programs.
Essential Job Functions:
* Supports all sterilization validation activities as required.
* Ensures compliance to divisional, Corporate, ISO, and EN requirements.
* Evaluates new or modified products for sterilization validation equivalency (adoption).
* Assist with evaluation of new or modified products for sterilization validation equivalency (adoption).
* Maintains processing specifications and required documents (Pallet Patterns, Sterilization Specification Sheets, Cycle Specifications, etc...) as needed.
* Assist with Process Deviation Failure Investigations and dispositions for Management approval.
* Supports preparation of all applicable protocols and reports for sterilization validations.
* Revise and/or develop SOPs to support sterilization program.
* Support cost savings programs.
* Perform supplier audits.
* Support other Bard facilities/division in routine product processing, as required.
Basic Qualifications:
Must possess the ability to schedule activities and work independently.
Must be detailed oriented.
Must possess knowledge about the physical, chemical, and biological sciences.
Must understand impact of environmental control, packaging, and manufacturing process on sterility assurance.
Thorough understanding of EO sterilization/validation requirements.
Must understand government regulated environment and quality systems.
Knowledge of hazardous chemical handling. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Statgraphics and Microsoft Word, Excel, and Access.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.
Additional Desirable Qualifications Skills and Knowledge:
LANGUAGE SKILLS Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures. Ability to communicate ideas articulately.
MATHEMATICAL SKILLS
Ability to apply mathematical concepts such as algebra, calculus, and statistics.
REASONING ABILITY
Possess strong decision making skills. Ability to effectively manage day to day decisions concerning sterilization projects. Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Judgment is crucial. Determining what is absolutely necessary and ensuring compliance with limited parameters is imperative. Decisions are made frequently on new or modified products and/or processes.
A high level of initiative is required. Day-to-day decisions about projects and validation programs are made frequently. Position may interface with internal and other division employees, contractors, and regulatory agencies.
Education and/or Experience:
* Bachelor's degree in biological, chemical sciences with engineering preferred.
* Three to five years of experience with process or sterilization validation in medical device industry, pharmaceuticals or biologics.
Physical Demands:
While performing the duties of this job the employee is regularly required to sit, use hands to fingers, handle or feel, reach with hands and arms, and talk and hear. The employee frequently is required to stand and walk. The employee is required to climb or balance and stoop, kneel, crouch or crawl. Must have the ability to lift occasionally at least 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
This position works in a normal office environment. The noise level in the work environment is quiet to moderate.
Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals.
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: QA Sterilization Engineer/Engineering
Job ID: 2009-3755
Standard Title: QA Sterilization Engineer
Career Level: experienced
Location/Division: Covington, GA/Bard Medical
Relocation: yes
Posted Date: 7/14/2009
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
The QA Sterilization Engineer position is located in Covington, GA at Bard Medical Division.
Summary of Position with General Responsibilities:
The QA Sterilization Engineer is responsible for directing and conducting the EO validation activities for all C.R. Bard divisions whose product is processed by Bard to include product evaluation for adoption into the sterilization program. This position also is responsible for technical studies and analysis to support the overall sterilization program and environmental monitoring programs.
Essential Job Functions:
* Supports all sterilization validation activities as required.
* Ensures compliance to divisional, Corporate, ISO, and EN requirements.
* Evaluates new or modified products for sterilization validation equivalency (adoption).
* Assist with evaluation of new or modified products for sterilization validation equivalency (adoption).
* Maintains processing specifications and required documents (Pallet Patterns, Sterilization Specification Sheets, Cycle Specifications, etc...) as needed.
* Assist with Process Deviation Failure Investigations and dispositions for Management approval.
* Supports preparation of all applicable protocols and reports for sterilization validations.
* Revise and/or develop SOPs to support sterilization program.
* Support cost savings programs.
* Perform supplier audits.
* Support other Bard facilities/division in routine product processing, as required.
Basic Qualifications:
Must possess the ability to schedule activities and work independently.
Must be detailed oriented.
Must possess knowledge about the physical, chemical, and biological sciences.
Must understand impact of environmental control, packaging, and manufacturing process on sterility assurance.
Thorough understanding of EO sterilization/validation requirements.
Must understand government regulated environment and quality systems.
Knowledge of hazardous chemical handling. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Statgraphics and Microsoft Word, Excel, and Access.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.
Additional Desirable Qualifications Skills and Knowledge:
LANGUAGE SKILLS Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures. Ability to communicate ideas articulately.
MATHEMATICAL SKILLS
Ability to apply mathematical concepts such as algebra, calculus, and statistics.
REASONING ABILITY
Possess strong decision making skills. Ability to effectively manage day to day decisions concerning sterilization projects. Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Judgment is crucial. Determining what is absolutely necessary and ensuring compliance with limited parameters is imperative. Decisions are made frequently on new or modified products and/or processes.
A high level of initiative is required. Day-to-day decisions about projects and validation programs are made frequently. Position may interface with internal and other division employees, contractors, and regulatory agencies.
Education and/or Experience:
* Bachelor's degree in biological, chemical sciences with engineering preferred.
* Three to five years of experience with process or sterilization validation in medical device industry, pharmaceuticals or biologics.
Physical Demands:
While performing the duties of this job the employee is regularly required to sit, use hands to fingers, handle or feel, reach with hands and arms, and talk and hear. The employee frequently is required to stand and walk. The employee is required to climb or balance and stoop, kneel, crouch or crawl. Must have the ability to lift occasionally at least 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
This position works in a normal office environment. The noise level in the work environment is quiet to moderate.
Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals.
