Production Operator

Job Title: Production Operator (II/III) / Sr. Operator

Location: Chantilly, VA
Pay Rate: $22–$30/hour
Shifts: 2nd Shift (4:00pm–12:30am) or 3rd Shift (12:00am–8:30am)

Experience Required: 2–20 years (Level II: 2–5 years, Level III: 5+ years OSD manufacturing)

Job Summary:
The Manufacturing/Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements, and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

Key Responsibilities:

• Operate pharmaceutical production machinery and follow procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, encapsulating, coating, potent compound, etc.
• Execute written SOPs to ensure the purity of materials involved in the manufacturing process.
• Properly use all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
• Examine manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
• Clean manufacturing equipment and facilities according to established SOPs.
• Execute machine changeovers from batch to batch.
• May sample batches for quality testing. Execute required in-process product quality checks and document accurately.
• Understand and run processes to meet the assigned schedule and standards/routers; when this is not achieved, participate in the debrief to understand the reasons why and what needs to be corrected moving forward.
• Complete documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
• Participate in troubleshooting process issues and continuous improvement projects.
• Adhere to all cGMP compliance/regulatory mandates and quality requirements.
• Maintain a clean, organized, work area.

Requirements:

• High School Diploma or equivalent experience required; Associate degree preferred.
• OSD manufacturing experience required.
• Experience with pharmaceutical Glatt, compression, and pan coating equipment is a plus.
• Proficient in running machinery, cleaning, sampling, and basic set-ups.
• Knowledge of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
• Basic math, reading, legible writing skills, and problem-solving abilities.
• Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator, and be able to wear all required PPE.

Job Type: Full-time

Pay: $ $30.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person