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Manufacturing Engineer

Description:

Position Summary: Design/ develop/ improve/ source manufacturing processes, equipment/ tools, and systems. Evaluate process and product design for manufacturability and suggest improvements for quality, cost reduction, and efficiency. Author, execute, and summarize validation protocols. Coordinate and manage validation project execution for equipment, critical utility, process, cleaning, and computer related systems. Ensure protocols, records, and procedures are in compliance with 21 CFR 11, 210, 211, & 820 and current Good Manufacturing Practices (cGMP).

 

Responsibilities include but are not limited to:

· Participate in New Product Introduction activities by evaluating the product design for manufacturability and manufacturing process for improvement opportunities. Participate in scale-up activities and product and process validation activities.

· Coordinate and execute validation studies (IQ, OQ, PQ etc): writing protocols, analyzing and documenting results, and generate final summary reports. Validation activities include but not limited to equipment/system qualification, packaging process validation, cleaning/ sanitization validation, and computer related systems validation.

· Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.

· Coordinate validation activities with support groups for timely protocol executions.

· Work with cross functional teams during the entire process life cycle and provide technical assistance and training as a subject matter expert.

· Assist in identifying, analyzing, and correcting design and manufacturing related issues for process optimization.

· Assess current manufacturing processes, equipment, tooling to identify and execute improvement opportunities.

· Assist in the development, design, and validation of new manufacturing processes, including tooling design and fabrication.

· Follow and recommend improvements as applicable in policies and procedures to management and maintain compliance with site, corporate and regulatory standards.

*Note* This opportunity involves eventual 30% travel to Tucson, AZ. Approx. 1 week a month pending health & safety of travel.

Skills:

manufacturing engineering, process improvement, IQ, OQ, PQ, npi, injection molding, cgmp, validation plan, solidworks

Top Skills Details:

manufacturing engineering,process improvement, IQ, OQ, PQ, npi, injection molding

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.

Company
ACtalent
Posted
07/21/2021
Type
Contractor
Location
TUCSON, AZ, US