Engineer - II

Qualifications:

Education Requirements: B.S. or B.A. in Engineering, Sciences, or related discipline. 2-4 yrs experience (combination of co-op/Real world acceptable).

Required Experience and Skills: Strong Technical Writing Skills, Highly developed communication, leadership and teamwork skills, Ability to manage projects/work to schedule/deadlines.

Preferred Experience and Skills: Deviation Management Investigation. Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Experience in root cause analysis. Experience in manufacturing environment. ability to meet quick pace/hard deadlines. Any previous SAP and/or Power BI experience beneficial

Responsibilities:

• Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents

• Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation

• Supports equipment and facility projects for the Sterile Supply areas.

• Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.

• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

• Designs, conducts, and/or reviews and approves experimental protocols as needed.

• Provides on-the-floor support of complex operational and technical (process/equipment) issues.

• Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-

First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.

• Supports team safety, environmental, and compliance objectives.

• Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

• • Partners effectively with Operations, Quality, Planning, project teams, Automation, Maintenance, and external vendors.