Deviation Management Specialist

1 month ago

West Point, United States Pyramid Consulting, Inc. Full time

Immediate need for a talented Deviation Management Specialist - I. This is a 12+ Months Contract opportunity with long-term potential and is located in West Point, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-46407

Pay Range: $35 - $41/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

  • Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations.
  • This individual will be responsible for providing scientific support for manufacturing areas within the Client s Manufacturing Division (MMD).
  • This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations.
  • Real-time troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, with the goal of fully understanding root cause and product impact and development of corrective/preventative actions is required.
  • Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required.
  • Off-shift work may be required.

Key Requirements and Technology Experience:

  • Skills-Deviation, Investigation, SAP, cGMP.
  • B.S./M.S. in Mechanical or Chemical Engineering degree or other science degree.
  • 0-3+ years of relevant work experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry.
  • Support of vaccine operations or technical services support.
  • Support of deviation investigations and/or project work.
  • Previous experience in writing investigations for atypical events in a manufacturing environment.
  • Experience with troubleshooting biotech equipment, barrier technology, and closed system processing.
  • Experience with, MEDS, SAP.
  • Ability to read Piping and Instrumentation Diagrams.
  • Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
  • Demonstrated ability to work both independently and as a part of a cross-functional team.
  • Excellent written and verbal communication skills.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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