OA Lab Support - Formatted Proof
Job Overview
Company : Lab Support, a division of On Assignment
Base Pay :
Other Pay :
$45,000 - $55,000 /Year
Employee Type :
Industry Type :
Job Type :
Required Education : Not Specified

Location :
Charlotte, NC (map it!Map it!)
Contact :
Not Available
Phone :
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Fax :
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Ref ID :
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About Us:
Lab Support, a division of On Assignment, is an international leader in placing scientific and engineering professionals in contract, contract-to-hire, and direct hire opportunities. Having pioneered a specialized staffing approach, most Lab Support Staffing Consultants possess a degree in science or engineering and a passion for the industry they represent.

With nearly three decades of experience, we successfully place professionals in industries such as biotechnology, medical device, pharmaceutical, food and beverage, environmental, chemical, and consumer care as well as government and academia.

Validation Engineer

Job Description

The Validation Engineer will be responsible for Equipment/Facility, Cleaning, Process, and Packaging validation activities to include: writing validation protocols, scheduling and performing validation tests, gathering and analyzing data, and writing final validation reports.

The individual will also participate in the development and execution of line trials and engineering studies. Applies scientific principles to resolve problems and recommend improvements in a cross functional team environment.

Individual should display strong written and verbal communication skills and works well in a cross-functional, team-based cGMP environment.

Individual will supply proof that manufacturing, packaging, and cleaning systems/processes consistently result in products or processes that meet established specifications and quality standards.

Job Requirements

Develop validation protocols

 Develop, and prepares validation protocols to challenge the all types of processes for validation of manufacturing and packaging processes, as well as cleaning processes.

 Design, develop, and prepare of validation protocols to challenge both mechanical and electrical, controls, and pneumatic processes for qualification of facilities and utilities installation and operation.

 Execute and/or assist in execution of validation protocols which consists of taking finished product and bulk samples, swabbing equipment surfaces for cleaning evaluation, and evaluating packaging processes. Equipment qualification execution entails analyzing equipment performance against stated performance criteria

 Review analytical data (chemistry and microbiological) in support of validation efforts.

 Compile/Analyze analytical validation data and test results and prepare documentation for FDA compliance.

 Provide necessary evidence to support proof that manufacturing, packaging, and cleaning systems/processes consistently result in products or processes that meet established specifications and quality standards.

 Attend meetings with production, packaging, engineering, quality assurance and research and development personnel to obtain the necessary information for protocol preparation.

 Coordinates validation activities associated with validation protocols with all support groups (Quality Assurance, Research and Development, Operations, Quality Control, Project Management, Engineering)

 Review detail of change activities for equipment qualifications and decides on revalidation requirements.

 Perform additional special projects as needed to support product release and/or technical service investigation activities

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

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