Production Operator I
On-siteMiddletown, Delaware, United States
Job Summary
Execute batch operations including dispensing, mixing, filling, and packaging while recording results contemporaneously per approved batch records. Set up, operate, and monitor assigned equipment such as tablet presses and fluid bed dryers within validated parameters, conducting in-process checks and making routine adjustments under supervision. Perform line clearances, execute CIP/SIP cleaning, and work in classified areas following aseptic techniques and gowning qualifications. Assist with basic troubleshooting, partner with Maintenance for repairs, and collaborate with QA, QC, and Engineering teams to support audits and investigations. Meet KPIs for right-first-time performance and yield while suggesting process improvements.
Required Qualifications
- 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 similar regulated/industrial setting
- 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
- Computer literacy
- Ability to stand/walk for extended periods (8–12 hour shifts)
- Ability to lift/push/pull up to 50 lbs
- Ability to work in controlled environments
- Ability to wear PPE (gowning, gloves, safety glasses, face coverings, hearing protection as applicable)
- Ability to work with exposure to chemicals, sanitizers/disinfectants, and routine noise levels within regulated limits
Desired Qualifications
- Bachelor's or technical certificate in a science/technical field
- Experience with MES/LIMS/ERP and electronic logbooks
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