Production Operator (II/III) / Sr. Operator

Job Title: Production Operator (Level II/III)

Location: Chantilly, VA 20151

Type: Full-Time

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Job Summary:

We are seeking highly skilled and detail-oriented  Production Operator II  and III  with dedicated Oral Solid Dose (OSD) pharmaceutical manufacturing experience.They will be responsible for the setup, operation, and sanitation of sophisticated pharmaceutical machinery spanning Granulation, Blending, Compression, Encapsulation, and Coating. They will ensure uncompromised product compliance with current Good Manufacturing Practices (cGMPs), strict Food and Drug Administration (FDA) regulations, and standard operating procedures (SOPs), while actively participating in continuous improvement loops to maximize manufacturing throughput.

Key Responsibilities

• Operate specialized solid dose pharmaceutical machinery to execute weighing, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, and encapsulating workflows.
• Set up, clean, and operate state-of-the-art manufacturing equipment, including advanced high-speed tablet presses and encapsulation machinery (e.g., Fette 3200i, Fette P 3030, MG2 Planeta, or Korsch XM 12).
• Execute written, multi-layered Standard Operating Procedures (SOPs) to guarantee the strict purity and structural integrity of all raw materials involved in the batch run.
• Utilize industrial scale systems precisely, completing accurate printouts, zeroing, setting tares, and conducting routine daily calibration verification per compliance regulations.
• Scrutinize manufacturer Product ID Labels, Quality Control (QC) release tags, and master Batch Production Records (BPR) to verify that staged materials are authorized for release.
• Execute mechanical machine changeovers from batch to batch, performing meticulous "Master Clean" and "Surface Clean" protocols on processing equipment and production bays.
• Extract batch samples for immediate quality testing and execute critical in-process product checks, documenting numerical measurements accurately.
• Document all administrative and physical processing steps within logbooks, chemical protocols, and Batch Production Records with high legibility and precision.
• Verify and attach all dispensary data logs and raw material weight tickets to matching batch pages in an accurate, chronological, and timely manner.
• Diagnose mechanical baseline equipment faults or formulation anomalies, escalating standard deviations from the batch router immediately to the Production Manager.
• Participate actively in at least one Lean Manufacturing or Six-Sigma continuous improvement project of moderate scope to optimize machine cycle times.
• Adhere to all regulatory containment mandates, actively participating in safety teams, start-up briefings, and incident debriefing sessions when processing potent compounds.

Required Skills & Qualifications

• Mandatory prior experience operating within an Oral Solid Dose (OSD) pharmaceutical manufacturing environment.
• High School Diploma, GED equivalent, or a college Associate Degree.
• Level II Requirements: Minimum of 2-5 years of progressive pharmaceutical manufacturing experience, displaying full operating proficiency in assigned core processing units.
• Level III Requirements: Minimum of 5+ years of advanced pharmaceutical manufacturing experience, with proven mastery across multiple processes and mechanical changeover structures.
• Strong practical math, mechanical reasoning, legible writing skills, and blueprint/router reading comprehension.
• Sound foundational working knowledge of FDA regulations, cGMP compliance, and documentation entry rules within a sterile or controlled work environment.
• Direct operational history handling Glatt systems, specialized Compression tooling, or Pan Coating machinery. (Preferred)
• Prior specialized exposure handling complex Pharmaceutical Granulation, Blending, or high-containment potent compounds. (Preferred)
• Active or prior industrial Forklift Certification. (Preferred)

Physical Requirements

• Physical capacity to stand continuously for long periods of time on an active manufacturing floor across shifts extending up to 12 hours.
• Ability to manually maneuver, lift, and position production assets or material drums weighing at least 50 pounds independently.
• Full physical eligibility to wear required Personal Protective Equipment (PPE) daily, including safety glasses, earplugs, steel-toe shoes, and respiratory protection (must pass standard respiratory fit testing).