Production Operator I (Pharmaceutical Manufacturing)

Location: Middletown, Delaware, United States. On-site role with 8–12 hour shifts in controlled manufacturing environments.

Company

hirify.global supports cGMP pharmaceutical manufacturing in a regulated production environment.

What you will do

• Execute approved batch-record manufacturing steps, including dispensing, measuring, charging, mixing, filtration, filling, capping, and packaging.
• Set up, operate, and monitor validated equipment such as blenders, tablet presses, coaters, encapsulators, roller compactors, fluid bed dryers, and mills.
• Perform and document in-process checks, routine adjustments, line clearances, changeovers, and equipment assembly or disassembly.
• Work in ISO 8–7 classified areas, follow aseptic techniques, complete gowning qualifications, and perform cleaning using CIP, SIP, or manual procedures.
• Complete batch records, logbooks, material and yield reconciliations, and notifications for deviations, OOS/OOT results, or atypical events.
• Support investigations, CAPAs, audits, equipment troubleshooting, maintenance activities, and collaboration with QA, QC, MSAT, Engineering, Supply Chain, Facilities, and EHS.

Requirements

• Bachelor’s degree or technical certificate in a science or technical field preferred.
• Experience operating pharmaceutical manufacturing equipment, including tablet presses, encapsulators, fluid bed dryers, roller compactors, blenders, or coaters.
• At least 3 years of experience in GMP manufacturing, food and beverage, biotech, medical device, or a similar regulated or industrial setting preferred; new graduates may be considered.
• Experience assisting with regulatory inspections and audits.
• Understanding of cGMPs, cleanroom behaviors, data integrity, batch records, SOPs, and P&IDs, with basic math and measurement skills.
• Ability to stand or walk for extended periods, lift, push, or pull up to 50 pounds, and work with PPE, chemicals, sanitizers, disinfectants, and routine noise.

Nice to have

• Experience with MES, LIMS, ERP systems, or electronic logbooks.
• Knowledge of lean manufacturing, 5S, or SMED improvement methods.

Culture & Benefits

• Work in a cross-functional, highly regulated manufacturing environment.
• Operate according to validated procedures and data-integrity expectations.
• Participate in continuous improvement focused on right-first-time performance, schedule adherence, yield, and 5S standards.
• Use required PPE, including gowns, gloves, safety glasses, face coverings, and hearing protection as applicable.