Manufacturing Technician

The Technician - Sterility Assurance TSMS (Night Shift) role provides continuous support of the parenteral operations to enhance and improve assurance of sterile product manufacture. This role works closely with Operations and Environmental Monitoring personnel during all aseptic production activities and is responsible for addressing any sterility or product quality related questions during manufacturing. The Technician will work closely with cross‑functional teams to address all unplanned events within the classified areas that may require remediation or aseptic interventions to be executed.

You will be expected to continue to develop a high level of expertise in aseptic processing within TS/MS whilst supporting the RTP Parenteral Facility. As designated by management, additional support for qualification/validation activities or other routine responsibilities within the TS/MS group could be assigned.

• The objective of the role is actively coaching, auditing, and communicating within the Aseptic Processing areas for the majority of shift. Must be an extension of Sterility Assurance within the classified areas to monitor and reinforce best aseptic practices.
• Ability to identify and report on events related to the maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Promptly communicates with Operations regarding aseptic techniques and behaviors of personnel.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly.
• Conduct periodic internal reviews or audits to ensure that procedures are followed.
• Lead and organize remediation activities from day‑to‑day unplanned events or shutdown activities.
• Lead, coach and mentor personnel on aseptic techniques and practices during manufacturing activities and when executing smoke studies or other qualification activities.
• Correcting and communicating proper aseptic technique when needed and communicating with supervisors as needed on corrected behaviors.
• Be a point of contact for aseptic operations and bioburden control
• Provide technical support for non‑routine investigations (e.g., deviations, complaints), including the execution of required studies.
• Execute or assist in qualification/validation activities to support the bioburden control of the facility or equipment
• Support other routine responsibilities with the TS/MS group, as assigned by management.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety‑related activities.

• High school diploma or GED
• Minimum 5 years of pharmaceutical experience supporting cGMP manufacturing
• Experience with parenteral drug product manufacturing
• Ability to work night shift on 2-2-3

The position is 12 hr. shifts on a 2-2-3 rotation. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off‑hour work may be required.

• Experience in aseptic processing, environmental monitoring, microbiology, equipment qualification and validation
• Ability to analyze data and solve problems
• Demonstrated strong written and verbal communication skills
• Previous experience with deviation and change management systems, including Trackwise