Engineer II

Job Description :

• 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 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.

Quals :

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,