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Senior Validation Engineer Opportunity
Hobart, NY (Upstate NY, Southwest of Albany).
RELOCATION OPPORTUNITY
Kelly Engineering Resources
Every day, Kelly Engineering Resources (KER) connects engineering professionals with opportunities to advance their careers.? We currently have an exciting direct hire opportunity for a Senior Validation Engineer in Hobart, NY.?
Summary of Position:
-?Lead, implement, and execute validation projects ranging from stand alone equipment, software validations, process capability studies, and Cleaning Validation and process improvements to expansion, new packaging lines and new product launch.
-?Provide guidance on the equipment/process/ software validation requirements and design control activities for new product development projects.
-?Coordinate with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP and any other appropriate regulations. .
-?Support technology transfer activities, process/ software characterization studies and gauge R R studies within the Manufacturing Process.
-?Support manufacturing and packaging with new product introductions, process improvements and provide technical support as required.
-?Ensure product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools and application of related pharmaceutical experience.
Principle Accountabilities for the Senior Validation Engineer include:
-?Lead/ support/conduct IQ, OQ, PQ validation studies of equipment and processes, utilities, and software validations including recipe control.
-?Develop/review and approve validation protocols and final reports using engineering experience and statistical process controls.
-?Select and utilize a wide range of appropriate statistical methodologies and techniques.
-?Develop and implement procedures to comply with Sector, Corporate and Industry standards.
-?Assist with multiple cross functional projects from development through release to production. Projects include new facilities startup, packaging line FAT and qualifications, and new product launch.
-?Execute activities in support of the Validation Department priorities with the assistance of the department manager.
-?Technical assistance during investigations of process/product issues. Generate and resolve validation deviations of process/product or equipment protocol discrepancies.
-?Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols.
-?Strong communication skills.
-?Prepare and maintain validation records in accordance with department procedures to ensure compliance with current standards.
Education and experience for the Senior Validation Enginee? include:
-?BS in Engineering Discipline or Masters Degree in Chemistry, Mechanical, or Electrical Engineering is preferred.
-?Minimum of 6 years of applied technical experience within validation experience in pharmaceutical manufacturing and packaging.
-?Strong technical and mathematical aptitude.
-?Training or certifications in regulatory and cGMP requirements is desired.
-?Strong computer literacy MS office products, statistical analysis Minitab and database usage.
-?Knowledge of statistical process controls is also required for equipment qualifications.
-?Working knowledge of DFMEA and PFMEA.
-?Working knowledge of GD T.
-?Individual must have solid oral dose knowledge and experience, worked with Cleaning Validation principals.
-?Able to calculate the residual carry over in following batch, Knows how to establish cleaning limits, and determine proper cleaning detergents for cleaning API s and excipients.
For immediate consideration, click the Apply Now button, or refer a friend by clicking the E-mail this job link provided.
About Kelly Engineering Resources
Kelly Engineering Resources® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly® as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests. Visit http://www.kellyengineering.com.
Kelly Services is an Equal Opportunity Employer
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Source: http://chemistryjobs.acs.org/jobs/5055726/senior-validation-engineer

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