Senior Production Operator - OSD Pharma Tablet Compression

About the role

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. This role is fully trained to operate designated equipment and to work effectively within a cross-functional team in a regulated environment. This job is at our new, state-of-the-art OSD plant in Middletown, DE. Relocation assistance will be considered.

Production Operations

• Perform manufacturing steps per approved batch records (e.g., dispensing, measuring, charging, mixing, filtration, filling, capping, packaging etc.) and record results contemporaneously.
• Set up, operate, and monitor assigned equipment (e.g., tablet presses, roller compactors, etc.) within validated parameters.
• Conduct and document in-process checks (pH, weight/volume, torque, visual inspection etc.) 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 (ISO 8–7) following aseptic techniques and environmental monitoring practices.
• Complete initial and periodic gowning qualifications; perform routine interventions per procedure.
• Perform equipment and area cleaning (CIP/SIP/manual) and document to meet cleanliness status/line clearance.
• Assist with basic troubleshooting; partner with Maintenance/Engineering for repairs and PMs.

Documentation & Quality

• 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.

Knowledge / Skills / Abilities

• 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.
• 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; able to use scales, pH meters, and hand tools.
• Computer literacy; experience with MES/LIMS/ERP and electronic logbooks a plus.

Physical & Work Environment Requirements

• Stand/walk for extended periods (8–12 hour shifts); lift/push/pull up to 50 lbs.
• Work in controlled environments; wear PPE (gowning, gloves, safety glasses, face coverings, hearing protection as applicable).
• Exposure to chemicals, sanitizers/disinfectants, and routine noise levels within regulated limits.