Job DescriptionJob DescriptionJob Title: Production Operator II / IIIDepartment: Manufacturing
Location: Chantilly, VA
Employment Type: Full-Time
Shifts Available:2nd Shift: 4:00 PM – 12:30 AM3rd Shift: 12:00 AM – 8:30 AM
Work Authorization Required: US Citizen or Permanent ResidentJob Summary:The Production Operator II/III is responsible for operating pharmaceutical manufacturing equipment in an Oral Solid Dose (OSD) production environment. The role includes weighing, blending, granulation, compression, encapsulation, coating, and cleaning activities, all while adhering to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOPs). Operators play a key role in ensuring product quality, process efficiency, and workplace safety.Key Responsibilities:Manufacturing Operations:Operate OSD pharmaceutical production equipment (e.g., Fette 3200i, P 3030, MG2 Planeta, Korsch XM 12).Perform machine setups, changeovers, cleaning, dismantling, and reassembly.Process materials through weighing, blending, granulating, drying, milling, compressing, encapsulating, coating, and other unit operations.Handle potent compound processing in a safe and compliant manner.Execute and document in-process checks (e.g., weight, hardness, thickness, appearance).Support process improvements and troubleshooting efforts.Documentation Compliance:Complete batch records, logbooks, and production-related documentation with accuracy.Follow GMPs and SOPs in all operational activities.Verify materials using product ID labels, QC release tags, and batch records.Cleaning Setup:Perform equipment cleaning (master and surface clean).Maintain cleanliness of production areas per SOPs.Support equipment changeovers for product transitions.Continuous Improvement:Participate in investigations, debriefings, and root cause analysis for process deviations.Engage in continuous improvement initiatives and operational efficiency projects.Team Collaboration:Collaborate with team members and other departments to meet production goals.Contribute to team morale, success, and effective communication.Required Qualifications:Education:High school diploma or equivalent required.Experience (Level-Based):Level II Operator:2–5 years of pharmaceutical manufacturing experience.Proficiency or certification in assigned areas.Level III Operator:5+ years of pharmaceutical manufacturing experience.Advanced proficiency or certification in key areas.Technical Skills Abilities:Experience in one or more of the following: Compression, Granulation, Encapsulation, Coating (including Wurster), Fluid Bed Drying, Bead Tower.Operation and maintenance of tablet presses and encapsulators such as Fette, MG2, Korsch, etc.Knowledge of cGMP, FDA regulations, Lean Manufacturing, and Six Sigma principles.Ability to read and follow batch records and SOPs in English.Basic math and problem-solving skills.Physical capability to stand for long periods, lift 50 lbs, climb ladders, and wear required PPE.Preferred (Nice-to-Have) Qualifications:Experience in Glatt, Pan Coating, or similar solid dose equipment.Participation in prior continuous improvement or lean projects.Forklift certification (may be required for some roles).Interview Process:Round 1: Virtual interview via Microsoft Teams.Round 2: On-site interview.
Offer contingent on background check and drug screening.Benefits:Relocation support (including temporary housing if applicable)Comprehensive healthcare package401(k) with company matchPaid Time Off (PTO)Full suite of employee benefits
