Production Operator (IIIII) Sr. Operator

Job Title: Production Operator (Level II/III)

Location: Chantilly VA 20151

Type: Full-Time

Job Summary:

We are seeking highly skilled and detail-orientedProduction Operator IIandIIIwith dedicated Oral Solid Dose (OSD) pharmaceutical manufacturing 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).

Required Skills:

Manufacturing