Production Operator I - III...

About the role

Granules Pharmaceuticals Inc. (GPI), a subsidiary of Granules India Ltd., is a rapidly growing generic pharmaceutical company in the US with sites in Chantilly and Manassas, Virginia. The Production Operator role involves processing drug products while ensuring compliance with cGMPs, customer requirements, and SOPs. The position requires following standard procedures, recognizing process issues, and contributing to efficiency and quality improvements. Operators work in assigned shifts (2nd shift: 3:00 PM – 11:30 PM EST; 3rd shift: 11:00 AM – 7:30 AM EST) and must complete a one-month training period during standard business hours. Overtime flexibility is required.

Responsibilities

• Operate pharmaceutical production machinery for tasks such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, compressing, encapsulating, coating, and handling potent compounds.
• Follow SOPs to ensure material purity and proper use of manufacturing equipment, including scales, with daily calibration verification.
• Verify raw material release by examining product ID labels, QC release tags, and batch production records.
• Clean manufacturing equipment and facilities per SOPs; execute machine changeovers between batches.
• Sample batches for quality testing and perform in-process product quality checks, documenting results accurately.
• Meet assigned schedule and standards; participate in debriefs when targets are not achieved to identify corrective actions.
• Complete detailed documentation, including batch records, protocols, and logbooks, with accuracy and timeliness.
• Verify manufacturing processes on batch production records (BPR) and provide status updates on operational challenges.
• Assist in troubleshooting process issues and escalate deviations from standard procedures to supervisors.
• Participate in continuous improvement projects of moderate scope and complexity.
• Adhere to cGMP compliance, safety protocols, and regulatory mandates; maintain a clean and organized work area.
• Conform to all training requirements, including company-mandated and machine-specific training.
• Collaborate within cross-functional teams and share knowledge to support project success.

Requirements

Trainee – Level I Operator

• High school diploma, GED, or college associate degree.
• Minimum of 1–3 years of experience in a labor-intensive environment.
• Forklift certification preferred.
• Ability to communicate and comprehend English both verbally and in writing.

Level II Operator

• High school diploma, GED, or college associate degree.
• Minimum of 3–7 years of OSD (orally disintegrating/solid dose) pharmaceutical manufacturing experience under cGMP.
• Forklift certification preferred.

Level III Operator

• High school diploma, GED, or college associate degree.
• Minimum of 7+ years of pharmaceutical manufacturing experience under cGMP.
• Certification in assigned area or demonstrated proficiency in required competencies.
• Forklift certification preferred.

Required Knowledge & Skills

• Strong background in solid dose manufacturing (OSD), including experience with compression, granulation, encapsulation, Wurster coating, coating, fluid bed dryers, or bead towers.
• Capable of cleaning, setting up, dismantling, and operating advanced equipment such as Fette 3200i, Fette P 3030, MG2 Planeta, or Korsch XM 12 tablet presses and encapsulation machines.
• Knowledge of FDA regulations, GMP, Lean Manufacturing, and Six Sigma principles.
• Solid working knowledge of procedures, techniques, tools, materials, and equipment relevant to the role.
• Basic math, reading, legible writing, and problem-solving skills.
• Proficient in sampling batches and participating in continuous improvement initiatives.
• Strong written communication skills: clarity, grammar, style adaptation, and numerical data presentation.
• Strong oral communication skills: clarity, persuasion, active listening, and group presentation ability.

Physical Requirements

• Ability to stand for extended periods (up to 12-hour shifts).
• Capable of maneuvering at least 50 pounds.
• Ability to climb ladders and wear required PPE, including safety glasses, earplugs, safety shoes, and respirators (passing associated tests/requirements).

Pay

$18 – $36 per hour, flexible based on experience, qualifications, and internal equity.