Aseptic Officer

Role Summary

The Aseptic Officer provides technical leadership and oversight of aseptic operations within a multi-product drug product manufacturing facility. This role ensures compliance with cGMP through execution of aseptic technique and media fill programs, supports contamination control initiatives, and partners with Quality, Validation, and Engineering to meet sterility assurance standards. Responsible for owning the Media Program for one of two isolator-based filling lines and for leading observation and training to sustain aseptic compliance.

Responsibilities

• Aseptic Program Leadership
  Lead the Aseptic Technique Program, including routine observation of critical operations, data trending, and CAPA implementation.
• Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
• Author, review, and maintain aseptic-related SOPs, reports, and training materials to align with regulatory expectations and site standards.
• Partner with Quality Assurance, Validation, and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
• Represent Manufacturing during internal and external inspections, demonstrating robust understanding and control of aseptic practices.

• Media Fill Program Ownership
  Lead the Media Fills supporting one of the site’s isolator-based filling lines.
• Author and implement media fill protocols, complete final reports, and perform data trending and risk analysis.
• Partner with Manufacturing, Quality, and Engineering to ensure execution aligns with aseptic process design, batch records, and contamination control strategy.
• Evaluate results, identify opportunities for process or operator improvement, and ensure timely closure of investigations and CAPAs.

• Contamination Control and Compliance Support
  Support contamination and cross-contamination control initiatives and provide aseptic expertise in investigations, deviations, and change controls.
• Participate in data reviews and trending related to aseptic or microbiological quality indicators as needed.
• Contribute to improvements in facility design, procedures, and behaviors that enhance aseptic performance and sterility assurance.
• Participate in partner and regulatory audits, provide required information, and respond to findings as appropriate.

• Operational Excellence
  Participate in Lean Transformation and continuous improvement initiatives; use problem-solving tools to identify and implement improvements to aseptic performance and process control.

Qualifications

• Required: Doctorate degree
• Required: Master’s degree and 2 years of operations or quality experience
• Required: Bachelor’s degree and 4 years of operations or quality experience
• Required: Associate’s degree and 8 years of operations or quality experience
• Required: High school diploma / GED and 10 years of operations or quality experience
• Preferred: 10+ years of biopharmaceutical or medical technology experience with increasing responsibility
• Preferred: Bachelor’s or Master’s degree in Microbiology, Life Sciences, or a related field
• Preferred: Demonstrated expertise in aseptic processing, isolator operations, and media fill program management
• Preferred: Experience supporting regulatory inspections and contamination control initiatives in a sterile manufacturing environment
• Preferred: In-depth understanding of cGMPs, aseptic technique, and sterility assurance principles
• Preferred: Familiarity with microbiological investigations, environmental monitoring data interpretation, and deviation management

• Education
• Bachelor’s degree and/or higher in Microbiology, Life Sciences, or a related field (as applicable per qualification requirements)