Manufacturing Technical Operations Specialist III (MTO Specialist)

$120k - $140k

Catalent

Catalent seeks a Manufacturing Technical Operations Specialist III to support gene therapy manufacturing operations at its FDA-licensed facility in Harmans, Maryland. The role involves batch record review, deviation management, root cause investigations, and continuous improvement activities within a CGMP environment.

Responsibilities

Initiate quality records, conduct deviation investigations, and lead root cause analysis with cross-departmental input
Develop, execute, and oversee Corrective and Preventive Actions (CAPAs) with technical leadership
Revise manufacturing documents including batch records and Standard Operating Procedures
Lead continuous improvement projects and provide real-time response to operational deviations
Support technology transfer, process monitoring, and data trending activities

Requirements

Master's degree in science/engineering/biotech plus 6 years GMP biopharmaceutical manufacturing experience; or Bachelor's plus 8 years; or Associate/high school plus 8-10 years
Strong GMP regulations, FDA requirements, and quality systems knowledge
Experience leading deviation investigations and root cause analysis for major and critical deviations
Technical writing and documentation authoring/revision capabilities
Cross-functional leadership, project execution, and stakeholder communication skills
Analytical problem-solving with Lean Six Sigma familiarity and multi-priority management ability
Ability to work in aseptic manufacturing environment with extended standing and cleanroom operations

Compensation: $120,000–$140,000 base plus bonus

Apply

Vacancy posted 7 days ago

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