We are looking for a Aseptic Filling Validation Specialist in walkersville, MD working at Lonza.
Develop complex aseptic processing cleanroom qualification protocols including HVAC qualification, Environmental monitoring, and media fill protocols for execution. This role also develops protocols for qualification of automated, semi-automated and manual aseptic filling processes.
Schedules and tracks Aseptic protocol executions. This includes coordination with Scheduling and Manufacturing.
Protocol close-out activities including drafting of summary reports, obtaining sample results via LIMS, maintaining execution tracker and discrepancy reports generation.
Work to identify efficiencies in Validation program approach. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to Aseptic Filling validation.
Perform assigned Quality Systems activities including: Document Management System (DMS), Information Management System (ProCal) and Trackwise system (Change Control, Deviations, CAPA, etc.).
Act as point person for customer communications as assigned
Participate in Audits and Inspections
Provide SME level expertise
Perform other duties as assigned.
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
All office areas, manufacturing areas and facility areas plant wide.
Education: Bachelor’s degree
Preferred area of study: Science or technical discipline.
Experience: Minimum 6 years of industry experience. Experience in performing aseptic cleanroom validation including aseptic process simulations.