Description:

Lead the generation, execution, and review of qualification/validation protocols and reports.

Lead the planning, implementation, and effectiveness verification of corrective and preventive actions.

Lead the generation, execution and review of method validations.

Assist production with the investigation of component and finished good non-conformances.

Assist supplier management and Quality Control with the investigation of sourced raw materials, components, and finished goods.

Monitor and investigate deviations from Quality System processes.

Review continuous improvement of quality systems, procedures, & executed records to determine gaps and to identify areas for improvement.

Review proposed technical changes and identify related impact to processes/procedures/ materials etc.

Generate and maintain specifications for raw materials, components, & finished product.

Perform risk assessments (FMEA, etc.) and initiate action plans.

Assist the QA Manager with gathering and analyzing data to determine performance of Quality and Operations (metrics).

Oversee the site calibration program.

Typical Day:

This position is rather fluid. They run 24:7, and the Engineer will need to bounce around depending on what happened the night before. They will have standing meetings several times a week with the team. Will also be answering emails, phones, perform monthly calibrations.

Validation Experience Mandatory

Skills:

Quality assurance, Capa, Quality engineering, Root cause analysis

Additional Skills & Qualifications:

Bachelor of Science Degree in engineering or science.

3 years process validation experience (IQ, OQ, PQ) is mandatory

ASQ Certified Quality Engineer or Six Sigma Black Belt Certification desired.

3 years of quality or engineering experience in an FDA regulated environment.

Sterile packaging and ETO sterilization desired.

Experience within a high-volume manufacturing facility strongly preferred

Excellent verbal and written communication skills.

Working knowledge of Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.