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Senior Process Engineer
Ref No.: 16-04025
Location: Philadelphia, Pennsylvania
Position Type:Contract
Start Date / End Date: 06/20/2016 to 12/20/2016
Job Title: - Senior Process Engineer
Location: - Lincoln, Nebraska
Duration: - 6 Months

Job Description:

OB PURPOSE: Accountable for the qualification of alternative supplier of API in solid dosage forms.
KEY RESPONSIBILITIES:
Develops an in-depth understanding of the API characteristics to avoid adverse process or quality changes due to switch between API.
Provides technical leadership to alternative API qualification. Provides justification of the API selected.
Expertise in the manufacture development of batches.
Will lead the manufacturing of scale up, development, stability, and validation batches.
Will be responsible for the generation of the documentation associated with these batches.
All work must meet appropriate required cGMP and Health & Safety standards
Demonstrated ability to write and/or review/authorize GMP-critical documentation, such as experimental reports, validation protocols, Batch Records, development and technology transfer reports.
The ability to perform Scale up/down from pilot to commercial scale
Demonstrated technical writing ability in order to write up/publishing internally and externally (as appropriate).
Lead document creation for stability batches, development batches and validation batches.
Provide information to update the health authority filings.
Manage activities of self and process engineer assigned to the task.
DIMENSIONS OF THE ROLE:
Basic Qualifications
Good sound knowledge and experience in various unit operations for solids manufacturing of direct blend and dry granulation products
Must have a Bachelor's Degree in Engineering, Science, or related discipline, with at least 5 years of industrial experience in Pharmaceutical or Healthcare industry.
Possess a proven comprehensive knowledge of Quality of Design (QbD), Process Understanding Control and Capability (PUCC) and associated tools and has demonstrated understanding of these tools as well as a comprehensive knowledge of relevant processing technology and equipment
Must have proven knowledge and demonstrate understanding of process validation principles and implementation of process validation protocols.
Must have good mathematical ability - statistics and design of experiments (DoE) experience and data analysis.