Aseptic Operations Specialist

About the Role
We are seeking an experienced Operations Aseptic Specialist to join our Aseptic Manufacturing team. The successful candidate will serve as a Subject Matter Expert (SME) in aseptic operations, ensuring compliance with regulatory requirements and best practices, driving continuous improvement, and supporting the delivery of sterile products of the highest quality.
Key Responsibilities

• Serve as a site Subject Matter Expert in Aseptic Manufacturing.
• Provide guidance and input for manufacturing process setup and batch records.
• Ensure operational procedures comply with regulatory requirements, safety, environmental regulations, GMP standards, and aseptic best practices.
• Utilize risk management tools (pFMEA, HAZOP, What-If analyses) to drive aseptic performance and sterility assurance.
• Collaborate with Quality, Engineering, and Aseptic teams to support manufacturing shifts and ensure safe, timely, and sterile batch production.
• Observe and provide feedback on aseptic technique and behaviors during critical activities such as cleaning, sanitization, aseptic setup, EM plate handling, and interventions.
• Lead and support investigations into process or product issues related to sterility, media fills, environmental monitoring excursions, and EMPQ, contributing to root cause analysis and CAPA.
• Analyze and trend environmental monitoring (EM) data, maintaining EM visualization tools and implementing action plans to address trends.
• Contribute to the continuous improvement of aseptic procedures and processes by interpreting and applying new regulatory requirements, developing best practices, and supporting site change control processes.
• Provide input on contamination control strategy, aseptic process simulation (APS) strategy, long-range planning related to aseptic manufacturing, and cleanroom/equipment design, qualification, and maintenance.
• Support regulatory audits as a subject matter expert in aseptic manufacturing and sterility assurance.
• Train operations personnel in aseptic techniques and aseptic processing procedures.
• Participate in leadership GEMBAs of manufacturing and testing areas to drive performance and engagement.

Qualifications & Experience

• Third-level degree in Science, Quality, or Engineering discipline.
• Minimum 5 years of experience in a GMP environment, with at least 3 years supporting aseptic manufacturing (non-negotiable).
• Strong knowledge of regulatory requirements, including EU GMP Annex 1, FDA 21 CFR Parts 210, 211, and 610, and relevant guidance documents.
• Expertise in risk management tools that drive aseptic performance, including contamination control strategies, pFMEA, HAZOP, and What-If analyses.
• Experience in tracking, analyzing, and trending environmental monitoring data.
• Proven experience in investigations related to sterility, media fills, EM excursions, and EMPQ, with ability to determine root cause and drive CAPA.
• Excellent communication and interpersonal skills with a focus on collaboration and leadership.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.