Manufacturing Associate Level 1

Lonza America•Walkersville, MD

3d•Onsite

About The Position

The Manufacturing Associate Level 1 participates in upstream and/or downstream aseptic manufacturing of LAL products in an ISO 5 environment, following company and departmental standard operating procedures. The role sets up and operates production equipment in LAL Filling and Finishing areas, inspects products, and packages finished kits. It also supports safe, compliant GMP manufacturing through required training, documentation, production-record completion, and adherence to procedures.

Requirements

Complete LAL Cleanroom General Training and qualify in aseptic processing, gowning, cleanroom equipment setup and usage, and environmental monitoring.
Qualify in the specified SAP transactions for LAL operations, including COR3, COR6, MIGO, and LS26.
Complete LAL Finishing General Training and qualify in finishing equipment setup and usage.
Qualify in the specified SAP transactions for finishing, including COR2, COR6, MIGO, MB1A, LB01, and LS26.
Demonstrate GMP documentation practices and follow standard operating procedures and production records.
Understand compliance requirements for executing GMPs in a manufacturing environment.
Comply with all safety policies and general regulations.
Meet yearly personnel utilization and training-compliance targets.

Responsibilities

Participate in upstream and/or downstream aseptic manufacturing of LAL products in an ISO 5 environment.
Set up and operate production equipment in the LAL Filling and Finishing areas.
Perform product inspections and final kit packaging of finished goods.
Follow safe-work practices, including safety chats, safety and EPS observations, and 6S.
Complete required cleanroom and finishing training, equipment qualifications, and SAP transaction qualifications.
Perform GMP documentation, product sample submission, proficiency testing inspection, and component kitting.
Follow standard operating procedures and complete production records while maintaining GMP compliance.
Support continuous improvement projects and meet personnel utilization and training-compliance targets.
Minimize operator-related PRs, personnel excursions during aseptic processing, and documentation errors.
Perform other duties as assigned.