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We have an immediate opening for Sr. Validation Engineer Please go through the below requirement and send me your updated resume to akil@globalpharmatek.com or please call me on 732- 228-4115 to discuss more about this position.
Title: Sr. Validation Engineer
Duration: 1 Year
Location: Northridge, CA
Job Description:
· The individual chosen for this position will primarily be responsible for executing tasks in support of process development, characterization, validation, and legacy support.
· In addition, this individual will be responsible for designing, coordinating, and carrying out in-vitro experiments critical to the business unit.
· The qualified candidate will make detailed observations, analyze data, interpret results, and develop strategies for implementing solutions.
· Prepare technical reports, summaries, protocols, and quantitative analysis. Maintain familiarity with current scientific literature.
· Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Position Responsibilities:
· Develop and characterize processes in support of the CGM business unit
· Operate and optimize process characterization through the use of different equipment
· Design, coordinate, and execute in-vitro experiments
· Document experiments and results in engineering reports and test plans
· Performs and coordinates efforts on performing validations, IQ/OQ/PQ
· Create and present summary presentations to management
· Collaborate and coordinate with outside vendors
· Applies product, process and system knowledge for the development and evaluation of products and processes.
· Provides technical support to engineering, and provides line support as required.
· Prepares, conducts and coordinates sample builds, test and process validation protocols (IQ/OQ/PQ).
· Obtains test data and provide statistical analysis to generate status reports for engineering.
· Routes and tracks all protocol documents for proper approvals.
· Performs First Article Inspections on parts.
· Initiates revision of controlled drawings of components and assemblies for design review.
· Writes and reviews procedures and prepares technical documents for appropriate approval.
· Supports the creation and development of new test methods to ensure that product is adequately tested and meets all stated requirements. Identifies areas for improvement in products, processes and systems and recommends changes. •Provides process expertise and training as necessary.
· Identifies safety issues in the immediate work environment and other work areas and recommends solutions for improvement.
Basic Qualifications:
· BS in Biomedical/Mechanical/Chemical Engineering
· Experience in working in a clean room environment and wet lab environment
· Experience in analyzing large data sets and performing relevant statistical analysis
· Proficient in writing technical reports, procedures, and/or reference documents
· Must have excellent verbal and written communication skills
· Must have experience in developing Design of Experiments (DOEs)
· Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
· Proficient in Minitab statistical analysis software
Education Required: Minimum BS in Biomedical Engineering
Years of Experience: 3-6 years of experience
Desired/Preferred Qualifications:
· MS in Biomedical Engineering
· Skilled in understanding mathematical algorithms
· Medical device or healthcare industry experience.
· Green belt
Thanks & Regards,
Akil R
15 Corporate Place S, Suite 345, Piscataway, New Jersey - 08854
US Tel : 732-543-7155 Ext.: 9055 | US Direct: 732- 228-4115 | Fax : 732-474-0144
akil@globalpharmatek.com | www.globalpharmatek.com
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