Search Jobs: Results: Quality Assurance Sterilization Engineer
PLEASE DO NOT APPLY IF YOU DO NOT HAVE AN ENGINEERING OR SCIENCE DEGREE AND THREE + YEARS OF ETO STERILIZATION PROCESS EXPERIENCE IN MEDICAL,PHARMACEUTICAL OR BIO-PHARMA
INDUSTRY.
Job Title: QA Sterilization Engineer
Reports To: Quality Assurance Manager, Global Sterilization
SUMMARY
The QA Sterilization Engineer is responsible for directing and conducting the EO validation activities for all corporate divisions whose product is processed 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 DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
· 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.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· 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.
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.
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.
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.
Job Details
| Name: | David Griffith | Date Posted: | 7/21/2010 |
| Office: | Charlotte | Telephone: | (704) 889-1100 |
| Email: | dgriffith@fpccharlotte.com | Fax: | |
| Category: | Medical Device | ||
| Keywords: | eto, eto sterilization,sterilization validation,cycle specifications,pallet patterns,deviation investigations, failure investigations,supplier audits,fda, epa regulations,exposure standards,statgraphics | Region: | |
| State: | GA | City: | Atlanta |
| Education: | BS | Job Number: | J83196-CLTT-DBG-972 |
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