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)

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.

• 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.

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

• Maintain clear production status boards and accurate BPR entries.

• Participate in process improvement initiatives and incident debriefs.

• Suggest improvements in efficiency, quality, and throughput.

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

• Maintain clean, organized work areas and proper gowning hygiene.

• Utilize required PPE including respirators when applicable.

• 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.

• 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.

• HS Diploma, GED, or Associate Degree

• 25 years pharmaceutical manufacturing experience

• Experience/certification in assigned manufacturing areas

• Forklift certification may be required

• 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

• 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