Pharmaceutical Validation Engineer in Atlanta, Georgia For Sale
Job Description
This position is in Gainesville, Georgia and is a great opportunity for someone who lives in - or is open to relocating - to the metro-Atlanta area. Gainesville is a 25 minute drive from the North Atlanta suburbs of Suwanee and Duluth.
Relocation is offered.
Primary Objective of Position
The Validation Engineer II is responsible for writing, executing, and reporting validation protocols and other relevant documentation. These protocols can include but not be limited to User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation, process validation and computer validation in support of the equipment, products, processes and computer systems. The position also requires the use of Risk Assessment tools and the execution of Periodic Reviews where appropriate. This person will also have responsibilities in the areas of process engineering and improvement, interfacing with Process Development and Manufacturing.
Major Duties/Responsibilities
Coordinate and perform validation projects and protocols in support of equipment, product, process and cleaning validation. (20%)
Write and review protocols and reports. (20%)
Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed. (20%)
Collaborate with R&D to ensure successful process development and technical transfer to Manufacturing. (10%)
Coordinate validation activities in support of assigned validation projects. (10%)
Recommend approval or failure of validation reports. (5%)
Provide support to manufacturing and packaging to ensure protocols are executed as intended. (5%)
Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation. (5%)
Be a resource to other departments for product and process knowledge. (5%)
Minimum Job Qualifications
Education
Bachelor?s degree in Engineering or Science Field
Experience
Five years relevant experience in pharmaceutical validation area. Consistently demonstrated validation proficiency, with advanced knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation systems. Experienced in current validation trends and processes.
Licenses, Certificates, Registrations
None
Knowledge/Skills/Abilities
Ability to read, write and interpret technical papers
Basic computer skills and knowledge of word processing software and spreadsheet software
Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
Good project management skills
Competent in leading technical projects
Competent in pharmaceutical compliance and regulatory policies
Knowledge of pharmaceutical industry guidelines, trends and practices
Act with professionalism and treat others with respect and consideration regardless of their status or position
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described her are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Physical Demands
While performing the duties of this job, the employee is regularly required to use hands to fingers, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is frequently required to stand and talk or hear; walk or sit; balance, stoop, kneel, crouch or crawl. The employee is expected to climb ladders and work at heights above ground.
The employee is occasionally required to push, pull and lift various pieces of equipment. The employee must regularly lift/carry up to 20 pounds and must occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Mental Demands
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently;
The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software.
The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.
Work Environment
In certain assignments, the employee will occasionally work outdoors; work in high precarious places; work near moving mechanical parts, fumes or airborne particles, and chemicals which may require the employee to wear specified Personal Protective Equipment..
The noise level in the work environment is usually moderate to loud.
Special Working Conditions
5% travel ? For training purposes or to act as company representative for FAT
*Salary offered depends on experience
Salary: $70,627.00 /year
Required experience:
Pharmaceutical Validation: 5 years
Apply Here: http://www.recruitersmap.com/jobs/view/xxxx8