Aseptic Operations Specialist – AOS 25-24676 Position Available In Montgomery, Pennsylvania
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Job Description
Aseptic Operations Specialist – AOS 25-24676
NavitsPartners West Point, PA 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
