Staff Engineer - Vaccine Process Technical Support - (US-NC-Durham - 27722)

Minimum Education: Tech School
Job Type: Full Time
Email this job to yourself or to a friend | Job Match Test | Resume Guide

Merck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.

Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Staff Engineer / Senior Engineer is responsible to assist in the technical start-up of selected sterile processing operations at the Vaccine Manufacturing Facility in Durham NC. As part of a plant team the engineer will plan design and implement varied technical projects and studies requiring knowledge of engineering and/or the physical sciences. Must embrace and help to establish an empowered team culture including significant interaction with manufacturing quality and automation groups. Also responsible for analytical and engineering studies associated with the development of new components products processes systems and facilities. Minimal supervision guidance and direction are employed by the supervisor; however periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.

Primary Activities:

Assists in the Shakedown and Operation Qualification phases of the capital project in aseptic processing areas such as media preparation vaccine filling lyophilization and capping/inspection unit operations. Subsequently assists in the execution of Performance Qualification for these same areas to include media challenge engineering runs and process validation lots of vaccine product.
Provides input to the Manufacturing Execution System (MES) development process team on technical aspects of process functionality and provides the content of vaccine Master Batch Records (MBRs) with knowledge of vaccine products and critical process parameters (CPPs).
Analyzes complex processing problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments.
Development of sound scientific justification for planned material and process and equipment changes.
Analysis of current and proposed safety/environmental policies guidelines and standards and assessment of compliance status of facilities.

Required:

A Bachelor of Science degree in Chemical or Mechanical Engineering
Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
Demonstrated written and verbal communication skills.
A minimum of 2 years experience in Production or Technical/Process Development in an FDA regulated environment.

Desired:

M.S. in Chemical or Mechanical Engineering
Experience with aseptic processing Site Master Formulas or manufacturing/filling process descriptions (batch sheets).
Production Qualification and/or Validation experience in aseptic processing areas

To apply copy and paste the link below into your browser:

http://www.asian-jobs.com/view.php?job_id=39549&type=search&auth_sess=ed6dc088fa9cdeb507b09162b7d1106c&ref=b9637a0932e29219070b3ca5e

There are so many more positions in any industry in all cities and states available on our website. Asian-Jobs.com specializes in jobs for bilingual English/Asian-speaking professionals and applying to all jobs is free. Take a look, there are many wonderful opportunities available. Go directly to www.Asian-Jobs.com