Sr Production Operator II/III – Pharma

Job Description

### **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