
Senior Aseptic Processing Specialist
6 days ago
As a Microbiology Operations Leader, you will play a critical role in ensuring the site's sterility assurance programs align with global and regulatory standards.
">Key Responsibilities:
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- Develop and implement contamination control strategies and management plans to ensure continuous improvements in sterility and aseptic manufacturing.">
- Oversee and manage the site's Sterility Assurance program, serving as the primary subject matter expert for all sterility assurance and microbiology-related matters during regulatory inspections and client audits.">
- Lead and guide all aspects of aseptic processing, including environmental monitoring, media fills, smoke studies, and critical batch operations.">
- Manage and mentor the Sterility Assurance team, providing clear direction, performance feedback, and professional development opportunities.">
Requirements:
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- Master's degree in Microbiology, Biology, or a related scientific field.">
- Minimum of 10-15 years of proven experience in a cGMP-regulated industry, with at least 2-3 years in a leadership or managerial role focused on sterility assurance.">
- Expert knowledge of aseptic processing, cleanroom operations, environmental monitoring, and contamination control.">
- Extensive experience with regulatory inspections (e.g., USFDA, EMA) and a deep understanding of cGMP, ISO, and other relevant regulatory guidelines.">
- Strong leadership, project management, and problem-solving skills, with a focus on root cause analysis.">
- Excellent technical writing, verbal communication, and interpersonal skills.">
- Proven ability to lead, mentor, and develop a team of professionals.">
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