Aseptic Operations Specialist - AOS 25-24676
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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