Process Engineer

Location: Kalamazoo, MI
Department: Azzur Solutions, LLC

Job Description

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.

Job Description:

The Process Engineers  will support project activities to support equipment start-up, systems integration, process optimization, and cycle time reductions in our COVID19 vaccine formulation facilities.  Work is required 7 days per week. Automation and Process Engineering teams must rotate to fully cover 3 shifts 7 days per week.

ROLE RESPONSIBILITIES:

 Provide 24x7x365 project support of our automation systems, formulation equipment and formulation facilities in our COVID19 vaccine formulation and freeze facilities
 Perform process engineering and automation activities to support equipment start-up, systems integration, process optimization, and cycle time reductions of our COVID19 vaccine formulation facilities. This may include documentation development, SOP drafting, sequence of operation optimization and documentation.
 Follow standard operating procedures and standards in a highly regulated environment.
 GMP verification protocol generation and execution.
 Develop new and follow existing standard operating procedures and programming guidelines.
 Design, develop, deploy and test our automated processes, systems and equipment. Contribute substantially to the interpretation of results and the design of subsequent activities.
 Maintain and support automation computing infrastructure.
 Adhere to safe work practices and develop standard operating procedures and system support documentation.
 Clearly communicate progress and issues to management and peers and finalize report writing for test protocols.
 Perform all tasks in strict compliance with operating procedures, best practices, and regulatory requirements.
 Provide feedback to leadership regarding potential issues and concerns with documentation.
 Accountable for accurately completing GMP documentation. 

QUALIFICATIONS:

Process Engineers:
 Minimum 3 years related process engineering experience. Preferred experience in aseptic environments including formulation, filling, freeze drying, and/or bio tech. BA/BS in chemical engineering, industrial engineering, or technology related field. Understanding automated process equipment, systems architecture and operations, and related components.
 ~1 year process experience in a GMP environment strongly preferred.


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