New 
Engineer II
 Spectraforce Technologies | |
 United States, Pennsylvania, West Point | |
 Oct 01, 2025 | |
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Engineer II 12 months West Point, PA19486 Comments/Special Instructions This role will require Deviation Management work. Needs GREAT communication (written/spoken) skills. Ideal candidate has combination of Internship/Co-op and Real World experience 2-4+ yrs total experience. Organized, meet deliverables/deadlines Completing Deviation report includes gathering evidence, interviews with groups- needs to have comfort with investigations, asking questions (not afraid), gathering evidence. Good at technical writing 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, 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 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. | |