Senior Production Operator (Pharma Tablet Compression)

TL;DR

Senior Production Operator (Pharma Tablet Compression): Operating and documenting cGMP pharmaceutical manufacturing processes at an OSD tablet production plant with an accent on tablet compression equipment, cleanroom operations, and right-first-time execution. Focus on setting up and troubleshooting validated equipment, performing in-process checks, maintaining data integrity, and supporting investigations and continuous improvement.

Location: On-site in Middletown, Delaware, United States. Relocation assistance will be considered.

Company

hirify.global provides pharmaceutical and life-science research, development, and manufacturing services.

What you will do

• Execute approved batch manufacturing operations, including dispensing, measuring, mixing, filling, packaging, and tablet compression.
• Set up, operate, monitor, assemble, and disassemble tablet presses, roller compactors, and other validated production equipment.
• Perform in-process checks, line clearances, changeovers, cleaning, gowning, and environmental monitoring in ISO 8–7 classified areas.
• Complete batch records, logbooks, material reconciliations, yields, and electronic production documentation accurately.
• Report deviations, OOS/OOT results, and atypical events while supporting investigations, CAPAs, audits, and inspections.
• Collaborate with QA, QC, Engineering, MSAT, Supply Chain, Facilities, and EHS on troubleshooting and process improvements.

Requirements

• Required experience with tablet presses, encapsulators, fluid bed dryers, roller compactors, blenders, coaters, or comparable pharmaceutical manufacturing equipment.
• At least 3 years of experience in GMP manufacturing or a similar regulated or industrial environment is preferred; new graduates may be considered.
• Working knowledge of cGMPs, cleanroom behaviors, data integrity, batch records, SOPs, and P&IDs.
• Ability to perform basic calculations and measurements using scales, pH meters, and hand tools.
• Ability to work 8–12 hour shifts while standing or walking for extended periods and lift, push, or pull up to 50 pounds.
• Bachelor’s degree or technical certificate in a science or technical field is preferred.

Nice to have

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

Culture & Benefits

• Work in a new, state-of-the-art OSD pharmaceutical manufacturing facility.
• Operate in a cross-functional, highly regulated environment focused on safety, quality, and right-first-time performance.
• Use PPE and follow controlled-environment procedures while working with chemicals, sanitizers, disinfectants, and routine production noise.
• Relocation assistance will be considered.