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Process Development Engineer
From:
Company: LifeCell Corporation (see all of this employer's jobs)
Phone: 9089471022
Fax: 1234567890
 Apply by eMail:do_not_reply@invalidemail.com
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Job Reference ID:
5038844
Category:
Facilities
Duration:
Fulltime, Permanent
City, ST:
Branchburg, New Jersey
Country:
United States |
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Description:
JOB SUMMARY/PURPOSE:
Designs and implements manufacturing/production processes, instrumentation and equipment, from lab through pilot plant to production scale-up to meet product and process design specifications.
PRINCIPAL RESPONSIBILITIES:
Identify specifications for the manufacturing/production processes, instrumentation and equipment, from lab through pilot plant to production scale-up to meet product/process design specifications.
Conduct appropriate studies to demonstrate the ability of the product/device to function as intended (i.e. verification and validation process).
Design and develop processes for manufacturing clinical and commercial tissue products, using statistics based experimentation and principles of process excellence.
Interface with various departments to ensure processes and designs are compatible for new product technology transfer.
Develop study protocols, technical reports, new process Standard Operating Procedures (SOPs), batch records and other documents as required.
Provides the necessary documentation to support regulatory filings such as 510k, IDE and PMAs as required.
Develop custom pilot scale and manufacturing equipment; develop and implement plans for IQ, OQ and PQ of the equipment with quality department.
Set-up a pilot scale manufacturing process for making clinical supplies under GMP conditions.
Work with in-house groups and vendors to ensure compliance of the facility.
Monitor the performance of processes and equipment and make recommendations for continuous improvement.
Work with the in-house manufacturing group to scale-up, validate and transfer the commercial manufacturing process.
Support process development function on R&D Technology Development Projects.
QUALIFICATIONS:
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Wed Oct 07 2009 05:59:10 AM
Last Modified: Fri Nov 20 2009 06:17:54 AM
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