Production Operator II / III (OSD Manufacturing)

Job Description

Job Description

Location : Chantilly, VA

Pay Rate : $22$30 / hour

Shift : Full-Time

Experience Required : OSD Manufacturing (Compression, Coating, Granulation, Encapsulation)

Job Summary

The Production Operator II / III performs manufacturing activities for oral solid dosage (OSD) drug products in compliance with cGMP, SOPs, and safety standards. This role operates a variety of pharmaceutical production equipment, completes documentation accurately, supports continuous improvement, and ensures efficient and safe execution of daily operations.

Key Responsibilities Manufacturing Operations

Operate pharmaceutical equipment used for weighing, blending, mixing, granulation, pellet coating, drying, milling, compression, encapsulation, coating, and potent compound handling.

Perform machine setups, changeovers, basic maintenance, and equipment cleaning (Master Clean / Surface Clean).

Execute all SOPs and Batch Production Records accurately to ensure product purity and compliance.

Conduct in-process quality checks, sampling, and documentation.

Verify raw materials using QC release tags, labels, and BPR requirements.

Troubleshoot process-related issues and support root-cause investigations.

Documentation

Complete batch records, logbooks, and weight verification tickets with accuracy.

Maintain clear production status boards and accurate BPR entries.

Continuous Improvement

Participate in process improvement initiatives and incident debriefs.

Suggest improvements in efficiency, quality, and throughput.

Safety Compliance

Follow all cGMP, FDA, SOP, and safety standards.

Maintain clean, organized work areas and proper gowning hygiene.

Utilize required PPE including respirators when applicable.

Teamwork Training

Collaborate with cross-functional teams within manufacturing.

Train and support peers in equipment operation and cleaning.

Participate in meetings, safety teams, and start-up discussions.

Required Skills Abilities

Proficient in operating OSD manufacturing equipment (Compression, Encapsulation, Coating, Granulation).

Ability to perform equipment cleaning, basic setup, and sampling.

Strong understanding of cGMP, SOPs, and regulated manufacturing requirements.

Ability to read and interpret instructions, manuals, and documentation.

Basic math, reading, communication, and problem-solving skills.

Ability to work independently and meet production targets.

Experience Education Level II Operator

HS Diploma, GED, or Associate Degree

25 years pharmaceutical manufacturing experience

Experience / certification in assigned manufacturing areas

Forklift certification may be required

Level III Operator / Sr. Operator

HS Diploma, GED, or Associate Degree

5+ years pharmaceutical manufacturing experience

Strong knowledge of :

Compression (Fette 3200i / P3030 / Korsch XM 12)

Encapsulation (MG2 Planeta)

Coating / Wurster coating

Granulation Blending (preferred)

Understanding of FDA regulations, Lean / Six Sigma, GMP

Physical Requirements

Ability to stand for long periods (up to 12-hour shifts)

Lift / maneuver up to 50 lbs

Climb ladders and operate equipment

Wear full PPE including respirators, safety glasses, ear plugs, and safety shoes