Job Description

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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