Aseptic Operations Specialist - AOS 25-24676


Non-IT - PA - West Point, PA
West Point, Pennsylvania
Locations: West Point, Allentown, Philadelphia, Pittsburgh
Posted On: July 08, 2025
Last Day to Apply: July 29, 2025
Pay: $41.00 per hour

Title: Aseptic Operations Specialist

Location: West Point, PA 19486
Duration: 12 Months

Qualifications:

  • B.S./M.S. degree in an engineering or scientific field
  • 0–3+ years of post-Bachelor’s experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related roles) within the pharmaceutical/biotech industry
  • Prior experience writing investigations for atypical manufacturing events
  • Familiarity with Lean Six Sigma methodologies and strong analytical/problem-solving skills
  • Proven ability to manage goals, timelines, and organizational tasks efficiently
  • Excellent verbal and written communication skills
  • Ability to work independently and within a cross-functional team

Preferred Skills:

  • Environmental monitoring experience
  • Experience in formulation and filling processes
  • Line manufacturing expertise (project engineering, maintenance, and facility engineering)
  • Background in bulk/drug substance manufacturing

Responsibilities:

  • Provide day-to-day technical support for manufacturing operations, addressing process deviations and developing corrective/preventative actions
  • Lead manufacturing investigations, troubleshoot issues, and apply scientific problem-solving principles
  • Collaborate with cross-functional teams supporting aseptic manufacturing, testing, planning, and release functions
  • Conduct root cause analysis for laboratory test failures and atypical manufacturing events
  • Implement analytical thinking to resolve complex challenges in production
  • Off-shift work may be required

Key Skillsets:

  • Technical writing and investigation expertise
  • Strong project management abilities, including meeting goals and timelines

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