Production Operator

WuXi AppTec•Middletown, DE

About The Position

Operator I supports cGMP pharmaceutical manufacturing activities by executing batch operations, cleaning and setup, in-process checks, and documentation with a strong focus on safety, quality, and right-first-time performance. The role is fully trained to operate designated equipment and work effectively within a cross-functional team in a regulated environment. Prior experience within oral solid dosage manufacturing is required. The position performs manufacturing steps according to approved batch records; sets up, operates, and monitors assigned equipment; conducts and documents in-process checks; and supports line clearances, changeovers, cleaning, and equipment troubleshooting. Work includes classified ISO 8–7 areas and requires compliance with procedures for gowning, aseptic techniques, environmental monitoring, and equipment and area cleanliness. The operator completes batch records and other documentation, reconciles materials and yields, initiates notifications for atypical events, and supports investigations, audits, sampling, and quality activities. The role collaborates with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, EHS, and other teams, and contributes to performance goals and process improvements. The work requires extended periods of standing and walking during 8–12 hour shifts, lifting, pushing, or pulling up to 50 lbs, wearing applicable PPE, and working in controlled environments with exposure to chemicals, sanitizers, disinfectants, and routine noise within regulated limits. The employer is an equal opportunity employer. Duties may include other job-related responsibilities as requested by Management.

Requirements

Prior experience within oral solid dosage manufacturing is required.
Bachelor’s degree or technical certificate in a science or technical field is preferred.
Experience working with tablet presses, encapsulators, fluid bed dryers, roller compactors, blenders, coaters, and/or other pharmaceutical manufacturing equipment.
Minimum of 3 years in GMP manufacturing, food/beverage, biotech, medical device, or a similar regulated/industrial setting is preferred; the posting also describes the role as new-grad friendly.
Experience assisting in regulatory inspections and audits.
Ability to work in a fast-paced, highly regulated environment.
Fundamental understanding of cGMPs, cleanroom behaviors, and data-integrity expectations.
Ability to learn and operate production equipment and read P&IDs, batch records, and SOPs.
Basic math and measurement skills, including ability to use scales, pH meters, and hand tools.
Computer literacy; experience with MES/LIMS/ERP and electronic logbooks is a plus.
Ability to stand and walk for extended periods during 8–12 hour shifts.
Ability to lift, push, or pull up to 50 lbs.
Ability to work in controlled environments and wear applicable PPE.
Ability to work with exposure to chemicals, sanitizers/disinfectants, and routine noise levels within regulated limits.

Nice To Haves

Experience with MES/LIMS/ERP and electronic logbooks.

Responsibilities

Perform manufacturing steps according to approved batch records, including dispensing, measuring, charging, mixing, filtration, filling, capping, and packaging, and record results contemporaneously.
Set up, operate, and monitor assigned equipment within validated parameters.
Conduct and document in-process checks, including pH, weight/volume, torque, and visual inspection, and make routine adjustments under supervision.
Execute line clearances and support changeovers, including equipment assembly and disassembly between production batch runs.
Work in classified ISO 8–7 areas while following aseptic techniques and environmental monitoring practices.
Complete initial and periodic gowning qualifications and perform routine interventions according to procedure.
Clean equipment and areas using CIP, SIP, or manual methods and document cleanliness status and line clearance.
Assist with basic troubleshooting and partner with Maintenance/Engineering on repairs and preventive maintenance.
Complete batch records, logbooks, and forms accurately and legibly; reconcile materials and yields.
Initiate notifications for deviations, OOS/OOT, or atypical events and support investigations and CAPAs as needed.
Participate in audits, room and equipment release, and lot sampling activities.
Meet or exceed KPIs, including Right-First-Time, schedule adherence, yield, and 5S audit scores.
Suggest and help implement process and documentation improvements, including lean, 5S, and SMED.
Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS.
Perform other job-related duties as requested by Management.