Job Description

Position Title : Production Operator I - III (Solid Dosage/OSD Manufacturing)

Location : Chantilly, VA

• Manufacturing Job Type: Full-time

Shift Availability

• 1st Shift: 7:00 am - 3:30 pm EST
• 2nd Shift: 3:00 pm - 11:30 pm EST Training: Must be available for training from 8:30 am - 5:00 pm EST for one month.

Job Summary

The Production Operator is responsible for tasks associated with drug product processing, ensuring adherence to current Good Manufacturing Practices (cGMPs), customer specifications, and Standard Operating Procedures (SOPs). Tasks may vary in complexity, scope, and sequence, and the role requires recognizing issues to improve efficiency, throughput, and quality. Operators manage production schedules and contribute to troubleshooting process issues, ensuring safe, efficient operations.

Key Responsibilities

Production

• Operate pharmaceutical production machinery, following procedures for manufacturing activities such as weighing, blending, dispensing, mixing, granulating, drying, compressing, and encapsulating.
• Adhere to SOPs to ensure material purity and proper equipment usage.
• Verify materials against Product ID Labels, QC release tags, and Batch Production Records.
• Clean and perform machine changeovers, conduct in-process product quality checks, and document results accurately.
• Follow assigned schedules and participate in debriefs to address any production issues.

Documentation

• Maintain accurate documentation of manufacturing processes in batch records, logbooks, and protocols.
• Complete and attach verification tickets, updating status boards as needed.

Continuous Improvement

• Assist in troubleshooting, participate in improvement projects, and address deviations with the supervisor.

Safety & Compliance

• Comply with all cGMP, SOP, policy, and safety requirements.
• Participate in safety meetings and maintain a clean, organized work area.

Training

• Fulfill all training requirements, including machine-specific training.

Teamwork & Collaboration

• Share knowledge with team members, contributing to the overall success of projects and initiatives.

Requirements

Trainee - Level I Operator:

• High school diploma, GED, or Associate Degree.
• 1-3 years of experience in a physically demanding environment.
• Proficiency in English (verbal and written).

Level II Operator (OSD/Solid Dose Manufacturing Experience Required)

• High school diploma, GED, or Associate Degree.
• 3-7 years of experience in OSD pharmaceutical manufacturing.
• Forklift certification may be required for specific roles.

Level III Operator (OSD/Solid Dose Manufacturing Experience Required)

• High school diploma, GED, or Associate Degree.
• 7+ years of pharmaceutical manufacturing experience, with relevant certification or demonstrated proficiency.

Required Knowledge & Skills For Levels II & III

• Experience in solid dose manufacturing (OSD) and equipment operation.
• Proficiency in areas like Compression, Granulation, Encapsulation, Coating, etc.
• Familiarity with FDA regulations, GMP, Lean Manufacturing, and Six Sigma principles.
• Basic math, reading, and problem-solving skills.
• Ability to participate in Continuous Improvement projects.

Physical Requirements

• Ability to stand for extended periods, lift at least 50 pounds, climb ladders, wear a respirator, and all required PPE (safety glasses, earplugs, safety shoes).

Apply if you’re eager to contribute to high-quality production in a regulated environment with opportunities for growth.

Send us an email to [email protected] and tell me why you’re interested.

Job Tags

Similar Jobs