Packaging Operator - Shift

Company Overview

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. Our facilities are located in Bloomington, Indiana, US and Halle/Westfalen, Germany. We specialize in pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization.

The Packaging Operator works within the Finishing/Packaging Complex. The primary responsibilities include inspecting, labeling, and packaging pharmaceutical products to meet client demand and expectations. The role ensures teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. This position reports to the Finishing Supervisor.

Shift: 3 Hours – 10:45 PM to 6:45 AM

• Label, package, and document per written instructions
  • Package product in boxes, cartons, syringes, vials, and blisters
  • Count materials/product to ensure accurate count
  • Apply labels to various components
  • Replenish packaging materials to areas/work cells as directed by Group Leader
  • Monitor and document TOR (time out of refrigeration)
  • Complete batch record protocol steps at the time of performance
• Inspect, verify, and track
  • Scan printed materials and manually examine printed materials and products to ensure specifications are met, including variable text printed online
  • Verify incoming materials for use
  • Inspect product/materials for defects
  • Perform bar code and systems challenges (as applicable) for equipment used
  • Complete end‑of‑batch reconciliation and count verification
  • Retrieve product samples
  • Monitor and ensure appropriate downtime and efficiency information is logged accurately
• Set‑up, tear down and clear
  • Participate and assist with line clearance activities
  • Remove batch‑related materials from production area
  • Ensure electronic inventory transactions for inventory tracking movement and material verification are completed
  • Clean and clear debris from all work areas
  • Dispose of rejects in the appropriate disposal area following reconciliation
  • Stage materials in the appropriate designated locations
  • Enter and verify information in logbooks, as needed
  • Apply representation samples to the batch records as required
  • Indicate appropriate signals with HMI (human‑machine interface) to track clearance, set‑up, time, etc.
• Other duties
  • Maintain attendance in accordance with the Bloomington Attendance Policy
  • Scheduled weekend overtime will be required
  • Visual acuity 20/20 with or without correctable vision and ability to pass color‑blind test
  • Ensure all safety practices are followed and keep area clean and clear of hazards

Controlled pharmaceutical environment that requires wearing long sleeves, safety toe shoes, gloves, and safety glasses. The role involves working in a team environment on a variety of automated and semi‑automated packaging lines.

• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job‑specific training materials
• Experience operating multiple types of packaging equipment, including barcode scanners, scales, and tape guns

• Occasional (0–33%): walking, climbing stairs and ladders, overhead reaching, lifting, balancing, kneeling, crouching, crawling; lifting up to 38 lbs; carrying up to 30 lbs.
• Frequent (34–66%): sitting, standing, reaching forward, object handling, fine hand coordination, operating controls; lifting and carrying up to 32 lbs; pushing/pulling up to 16 lbs.
• Other physical tasks: object handling, fine hand coordination, firm hand grasping.
• Final candidates must pass a post‑offer/pre‑employment job placement examination to verify physical capabilities.

• Education:
  
  High School diploma or GED required; 6 months of prior pharmaceutical or manufacturing experience preferred.
• Language:
  Must understand, speak, read, and write English to comply with SOPs, GMPs, and training materials.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental…