Position Title:Production Operator II / III (Compression, Coating, Granulation, Encapsulation)
Location: Chantilly, VA
Department: Manufacturing
Job SummaryThe Production Operator is responsible for performing pharmaceutical manufacturing activities in accordance with current Good Manufacturing Practices (cGMP), internal procedures, and quality standards. This role involves operating equipment, executing production processes, ensuring product quality, and maintaining a safe, clean, and compliant work environment. The operator will assist with process improvements, documentation, equipment maintenance, and support operational efficiency.
Key ResponsibilitiesProduction OperationsOperate and maintain pharmaceutical manufacturing equipment for processes such as weighing, blending, granulating, drying, milling, compressing, encapsulating, and coating.
Perform batch changeovers and assist in troubleshooting equipment and process issues.
Follow SOPs precisely to ensure product consistency, compliance, and quality.
Conduct in-process quality checks and maintain accurate production documentation.
DocumentationComplete batch records, logbooks, and weight verification tickets with accuracy and attention to detail.
Verify and document raw materials against batch production records.
Provide operational updates via status boards and reports.
Compliance & SafetyAdhere strictly to all cGMP, regulatory, and safety guidelines.
Participate in safety initiatives, incident reviews, and compliance discussions.
Maintain a clean and organized workspace, ensuring sanitation of equipment and production areas per SOPs.
Continuous ImprovementTeam Collaboration
Required Skills & CompetenciesHands-on experience in Oral Solid Dosage (OSD) manufacturing.
Proficiency in set-up, operation, and cleaning of pharmaceutical equipment (e.g., tablet press, encapsulation, coating systems).
Understanding of FDA regulations, cGMP, and pharmaceutical production processes.
Basic math, problem-solving, reading, and writing skills.
Ability to communicate in basic English (reading & speaking).
Comfortable standing for long periods, lifting up to 50 lbs, and working with PPE.
Preferred Equipment ExperienceTablet presses (e.g., Fette 3200i, P3030)
Encapsulation systems (e.g., MG2 Planeta)
Coating equipment including Wurster Coaters
Experience & EducationLevel II:
High School Diploma, GED, or Associate Degree.
2–5 years of pharmaceutical manufacturing experience.
Certification in assigned areas preferred.
Level III:
High School Diploma, GED, or Associate Degree.
5+ years of pharmaceutical manufacturing experience with proven proficiency in designated areas.
Work Environment & Physical RequirementsAbility to stand for extended hours (up to 12-hour shifts).
Ability to lift/move up to 50 pounds and climb ladders.
Must be able to wear required PPE including respirators, gloves, eye protection, ear plugs, and safety shoes.
Must-Have QualificationsOral Solid Dosage (OSD) manufacturing experience.
Equipment set-up and dismantling expertise (Compression, Encapsulation, Coating, Wurster).
Working knowledge of cGMP and production documentation.
Basic English communication skills (verbal and written).
This job description outlines the core duties and expectations for the Production Operator II/III role and may evolve based on business needs. Compliance with all safety, regulatory, and organizational standards is essential.