Production Operator II/III - Pharma

Location: Chantilly, VA

Job Type: Full-Time

Work Authorization: US Citizen, Green Card Holder, or H1B Transfer

Position Overview

We are seeking skilled Production Operators (Level II & III) with strong Oral Solid Dosage (OSD) manufacturing experience to join a pharmaceutical manufacturing team in Chantilly, VA.

The Manufacturing/Production Operator is responsible for executing drug product processing activities in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and established Standard Operating Procedures (SOPs). This role requires hands-on experience in solid dose manufacturing environments and the ability to operate, clean, set up, and troubleshoot advanced pharmaceutical equipment.

Candidates must come strictly from the Pharmaceuticals or Nutraceuticals industry. Soft-gel manufacturing experience alone will not be considered.

Key Responsibilities

Manufacturing Operations

• Operate pharmaceutical production equipment for weighing, blending, dispensing, granulating, drying, milling, compression, encapsulation, coating, pellet coating, and potent compounds
• Perform machine changeovers between batches
• Clean and sanitize equipment per established SOPs (Master Clean/Surface Clean)
• Conduct in-process checks and batch sampling for quality control
• Execute written SOPs to ensure material purity and product integrity
• Verify Product ID labels, QC release tags, and Batch Production Records (BPR)
• Ensure proper scale usage including zeroing, tare setting, and daily calibration verification
  
  

Documentation & Compliance

• Complete batch records, protocols, and logbooks accurately and thoroughly
• Verify and document manufacturing processes on BPR in a timely manner
• Maintain compliance with cGMP, FDA, and regulatory requirements
• Maintain a clean and organized work environment
  
  

Continuous Improvement & Team Collaboration

• Assist in troubleshooting and participate in continuous improvement initiatives
• Provide operational updates and participate in production debrief sessions
• Collaborate with cross-functional teams to meet production schedules and quality standards
  
  

Must-Have Qualifications

• Experience strictly in Pharmaceutical or Nutraceutical manufacturing
• Mandatory Oral Solid Dosage (OSD) manufacturing experience (no soft-gel-only backgrounds)
• Hands-on experience cleaning, setting up, dismantling, and operating tablet presses and encapsulation equipment
• Experience in one or more of the following areas:
• Compression (including Tri-Layer Press)
• Granulation
• Encapsulation (Hard-Gel)
• Wurster Coating
• Pan Coating
• Fluid Bed Dryers
• Bead Tower
• Ackley Laser Drill / Tablet Printing
• Strong knowledge of cGMP and regulated manufacturing environments
• Basic English communication skills (reading and speaking)
  

Preferred Experience

• Experience with equipment such as Fette 3200i, Fette P3030, MG2 Planeta, Korsch XM 12
• Strong background in Compression, Encapsulation, Coating, or Wurster Coating
• Experience in pharmaceutical granulation and blending
• Familiarity with Lean Manufacturing or Six Sigma principles
  
  

Education & Experience Requirements

Level II Operator

• High School Diploma, GED, or Associate Degree
• 2-5 years of pharmaceutical manufacturing experience
• Certification or demonstrated proficiency in assigned area
  
  

Level III Operator

• High School Diploma, GED, or Associate Degree
• 5 years of pharmaceutical manufacturing experience
• Advanced proficiency and certification in assigned area
  
  

Forklift certification may be required for certain roles.

Physical Requirements

• Ability to stand for up to 12-hour shifts
• Ability to lift/maneuver up to 50 pounds
• Ability to climb ladders and wear required PPE including respirators, safety glasses, ear plugs, and safety shoes