Location : Lincoln, NE
Job Type : Fulltime/Salary

Ideal Candidate will:
. Develop and lead initiatives that improve quality, product and/or compliance-related lab or manufacturing processes and systems.
. Process map and streamline processes using Six Sigma/Lean principles. Lead continuous improvement projects and leverage the use of Sharepoint to create defined, standardized, robust processes. Drive process control initiatives.
. Perform data analysis to support investigations or process improvements. Familiar with Mini-tab or equivalent statistical software. Lead root cause analysis investigations.
. Review and approve equipment qualification and process improvements. Identify and implement better validation approaches and utilize FMEA, DOE, process capability and other improvement tools.
. Provide compliance direction pertaining to regulatory requirements surrounding facility, manufacturing, packaging, and testing of pharmaceutical products.
. Perform internal audits for cGMP and quality system compliance placing a high emphasis on improvement.
. Provide key support during Regulatory/Health Authority agency audits (FDA, EU, etc.).

Minimum requirements
. Bachelor’s degree in chemical engineering, mechanical engineering or relevant field.
. 2-5 years relevant experience.
. Thorough knowledge of cGMPs and FDA regulatory requirements.
. Strong working knowledge of pharmaceutical processes and those manufacturing processes associates with APIs, raw materials, and packaging components.
. Excellent communication and interpersonal skills (oral and written).
. Preferred: pharmaceutical/biological manufacturing experience.
. Preferred: trained in Greenbelt, Blackbelt, or similar Six Sigma methodology.

The ideal candidate will be a team player, however this is definitely a role where individual contribution is valued.

Apply today!


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