Onsite Aseptic Production Technician - Cleanroom

Actalent; Elkhorn (WI); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Vacation & Sick Leave

Job summary

Actalent is seeking a Production Technician in Elkhorn, WI to execute aseptic operations inside ISO Class 5 cleanrooms, following cGMP, FDA guidelines, and USP standards. You will complete batch production records, maintain traceability, and ensure data integrity through SOPs.

Responsibilities include gowning and sanitizing tools, operating autoclaves, formulation vessels, and single-use filling lines, while monitoring equipment to minimize downtime and support environmental monitoring programs.

Qualifications

• Aseptic operations in ISO Class 5 cleanrooms.
• Follow cGMP, FDA guidelines and USP standards.
• Maintain batch records with traceability and data integrity.
• Strict aseptic gowning and sanitization of tools and equipment entering the cleanroom.
• Operate specialized manufacturing equipment including autoclaves and filling lines.
• Monitor production equipment to minimize downtime and troubleshoot as needed.

Responsibilities

• Execute aseptic operations including sterile compounding, filling, and capping.
• Follow cGMP, FDA guidelines, and USP standards in all production activities.
• Complete batch production records, logbooks, and yield calculations to maintain traceability.
• Perform aseptic gowning procedures and sanitize tools, materials, and equipment entering the sterile core.
• Operate autoclaves, formulation vessels, and single-use filling lines.
• Monitor and troubleshoot production equipment to minimize downtime.
• Support environmental monitoring by tracking air particulates and surface bioburdens in the cleanroom.
• Maintain QA by following SOPs and reporting deviations or issues.

Skills

Aseptic processing

cGMP compliance

Quality documentation

Equipment troubleshooting

Environmental monitoring

SOP adherence

Autoclave operation

Tools

Autoclaves

Single-use filling lines

Formulation vessels

Job description

Actalent is seeking a Production Technician in Elkhorn, WI to execute aseptic operations inside ISO Class 5 cleanrooms, following cGMP, FDA guidelines, and USP standards. You will complete batch production records, maintain traceability, and ensure data integrity through SOPs.

Responsibilities include gowning and sanitizing tools, operating autoclaves, formulation vessels, and single-use filling lines, while monitoring equipment to minimize downtime and support environmental monitoring programs.