Production Operator II/III - Pharma

Job Description

Location: Chantilly, VA

Job Type: Full-Time

Work Authorization: US Citizen, Green Card Holder, or H1B TransferPosition 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 ResponsibilitiesManufacturing 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 verificationDocumentation 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 environmentContinuous 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 standardsMust-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 principlesEducation Experience Requirements

Level II Operator

High School Diploma, GED, or Associate Degree

25 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

Full-time