Overview
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.
Responsibilities
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.
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.
Knowledge / Skills / Abilities:
- 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
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.