Engineer II -(Associate)
American Cybersystems, Inc.

Job Info

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Job Description: • 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 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. • Supports equipment, and facility projects for the Culture Media and Weigh and Dispense Operations, and Black Widow Spider 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, and external vendors.

Responsibilities: • 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 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. • Supports equipment, and facility projects for the Culture Media and Weigh and Dispense Operations, and Black Widow Spider 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, and external vendors.

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: Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Deviation Management Investigation.

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