Aseptic Operations Engineer

We are currently recruiting for an experienced Aseptic Manufacturing Subject Matter Expert (SME) to join a leading biologics manufacturing operation. This is an exciting opportunity for an engineering professional with strong aseptic manufacturing experience to play a key role in supporting sterility assurance, operational excellence, and continuous improvement across a state-of-the-art manufacturing facility.

The successful candidate will act as the technical SME for aseptic manufacturing equipment, cleanroom environments, and utility systems, ensuring systems operate in compliance with GMP, regulatory requirements, and aseptic best practices.

Key Responsibilities

• Act as the Subject Matter Expert for equipment, cleanroom, and utility systems related to aseptic manufacturing
• Ensure systems operate in compliance with safety, environmental, GMP, and aseptic manufacturing standards
• Monitor and support aseptic manufacturing engineering systems, including:
• Cleanroom performance (temperature, humidity, differential pressure, airflow velocity)
• Utility systems
• Critical equipment cycles including CIP, SIP, VHP, autoclaves, lyophilization, depyrogenation, and aseptic filling operations
• Support troubleshooting and investigations relating to equipment, utilities, and cleanroom systems
• Participate in investigations related to sterility assurance, media fills, environmental monitoring excursions, and contamination control
• Drive root cause analysis and CAPA implementation activities
• Support continuous improvement initiatives within aseptic manufacturing engineering systems and procedures
• Provide technical input into equipment, cleanroom, and utility system design activities
• Ensure engineering changes are managed through site change control procedures
• Lead projects related to aseptic manufacturing systems and equipment improvements
• Support preventative maintenance strategies for critical systems
• Participate in regulatory inspections and audits as the engineering SME for aseptic operations
• Contribute to contamination control strategies and aseptic process improvements
• Promote a strong quality culture, operational excellence, and continuous improvement mindset across the site

Requirements

• Degree qualification in Engineering or a related technical discipline
• Minimum 3 years’ experience within a GMP-regulated manufacturing environment
• At least 1 year of experience supporting aseptic manufacturing operations
• Strong understanding of GMP and aseptic regulatory requirements
• Experience supporting cleanrooms, utilities, and critical process equipment
• Project management experience is highly desirable
• Excellent communication and stakeholder management skills
• Strong problem-solving, investigation, and risk assessment capabilities

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