OSD Tablet Production Operator — GMP, Growth & Impact

WuXi AppTec Group; Town of Middletown (NY); On-site; USD 42,000 - 65,000; Full time

Job summary

WuXi AppTec Group seeks an Operator I for our new production facility in Middletown, DE. You will execute batch operations, perform setup and cleaning of designated equipment, and document results with a strong focus on safety, quality, and right-first-time performance.

You will work in a cross-functional, regulated environment, handling validated parameters, line clearances, and routine GMP tasks while supporting QA, QC, and MSAT teams.

Qualifications

• Bachelor’s or technical certificate in a science/technical field preferred.
• Experience working with tablet presses, encapsulators, fluid bed dryers, roller compactors, blenders, coaters and/or other pharmaceutical manufacturing equipment is required.
• Minimum of 3 years in GMP manufacturing, food/beverage, biotech, medical device, or similar regulated/industrial setting preferred (new-grad friendly).
• Experience assisting in regulatory inspections and audits.
• Ability to work in a fast-paced, highly regulated environment.

Responsibilities

• Perform manufacturing steps per approved batch records and record results contemporaneously.
• Set up, operate, and monitor assigned equipment within validated parameters.
• Conduct and document in-process checks and make routine adjustments under supervision.
• Execute line clearances and support changeovers, including equipment assembly and disassembly between production batch runs to minimize downtime.
• Work in classified areas following aseptic techniques and environmental monitoring practices.
• Complete initial and periodic gowning qualifications; perform routine interventions per procedure.
• Perform equipment and area cleaning and document to meet cleanliness status/line clearance.
• Assist with basic troubleshooting; partner with Maintenance/Engineering for repairs and PMs.
• Complete batch records, logbooks, and forms accurately and legibly; reconcile materials and yields.
• Initiate notifications for deviations, OOS/OOT, or atypical events; support investigations and CAPAs as needed.
• Participate in audits, room/equipment release, and lot sampling activities.
• Meet or exceed KPIs (Right-First-Time, schedule adherence, yield, 5S audit scores etc.).
• Suggest and help implement process and documentation improvements (lean, 5S, SMED).
• Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS.

Skills

cGMP understanding

Cleanroom procedures

Data integrity

Reading batch records

MES/LIMS/ERP experience

Education

Bachelor’s or technical certificate in science/technical field

Tools

MES/LIMS/ERP

Job description

WuXi AppTec Group seeks an Operator I for our new production facility in Middletown, DE. You will execute batch operations, perform setup and cleaning of designated equipment, and document results with a strong focus on safety, quality, and right-first-time performance.

You will work in a cross-functional, regulated environment, handling validated parameters, line clearances, and routine GMP tasks while supporting QA, QC, and MSAT teams.