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Engineer II -(Associate) Engineer II -(Associate)
Engineer II -(Associate) Engineer II -(Associate)TALENT Software Services • West Point, PA, US
Engineer II -(Associate) Engineer II -(Associate)

Engineer II -(Associate) Engineer II -(Associate)

TALENT Software Services • West Point, PA, US
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Base pay range

$40.00 / hr - $44.00 / hr

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.

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
  • Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Other
  • Industries

  • IT Services and IT Consulting
  • Referrals increase your chances of interviewing at TALENT Software Services by 2x

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    Engineer Ii • West Point, PA, US