Packaging Operator - Shift 3

Simtra US LLC; Bloomington (IN); On-site; USD 30,000 - 38,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) plan with company match

Paid holiday and time off

On-site workout facility

Job summary

Simtra US LLC in Bloomington, Indiana, is looking for a Packaging Operator to work in their Finishing/Packaging Complex. This role involves inspecting, labeling, and packaging pharmaceutical products, ensuring quality and safety standards are met.

The ideal candidate will have a High School diploma or GED and be able to work in a controlled pharmaceutical environment. Benefits include day one medical coverage, 401(k) plans, and paid time off.

Qualifications

• Education: High School diploma or GED required.
• 6 months of previous pharmaceutical or manufacturing experience preferred.
• Must be able to read and write English for compliance.

Responsibilities

• Label, package, and document pharmaceutical products.
• Inspect and verify product specifications.
• Participate in line clearance activities.

Skills

Good communication and interpersonal skills

Basic math skills

Good documentation skills

Understanding of SOPs

Familiarity with packaging equipment

Education

High School diploma or GED

Tools

Barcode scanners

Packaging machines

Job description

Simtra BioPharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring their sterile injectable products to market. Our facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization. We focus on cGMP manufacturing and provide additional services such as formulation development, lyophilization optimization, global regulatory support and secondary packaging.

Why join Team Simtra?

• Make it HAPPEN – we bring a growth mindset, developing new skills and exceeding expectations.
• Make it TOGETHER – we work as one, respecting each voice and tapping into our unique strengths.
• Make it RIGHT – we hold ourselves to a high standard of excellence, fulfilling commitments to the customer, patients and team members.
• Make it COUNT – we take pride in our daily work and strive to improve patient health.

This role: The Packaging Operator works within the Finishing/Packaging Complex. They inspect, label and package pharmaceutical products to meet client demand and expectations and contribute to an environment of teamwork, productivity, safety, identity, strength, purity and quality (SISPQ). The position reports to the Finishing Supervisor.

Shift: 3 Hours: 10:45 PM–6:45 AM

Responsibilities

• Label, package, and document per written instructions
  • Package product in boxes, cartons, syringes, vials, blisters.
  • Count materials/product to ensure accurate count.
  • Apply labels to various components.
  • Replenish packaging materials to areas/work cells as directed.
  • 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 products for specifications, including variable text printed on line.
  • Verify incoming materials for use.
  • Inspect product/materials for defects.
  • Perform barcode and system challenges as applicable.
  • 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.
  • Complete electronic inventory transactions for tracking and verification.
  • Clean and clear debris from all work areas.
  • Dispose of rejects in the appropriate disposal area following reconciliation.
  • Stage materials in 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
  • Maintain attendance in accordance with the Bloomington Attendance Policy.
  • Scheduled weekend overtime will be required.
  • Visual acuity 20/20 with or without corrective vision and ability to pass color‑blind test.
  • Ensure all safety practices are followed and keep area clean and clear of hazards.

Work environment

Controlled pharmaceutical environment with required personal protective equipment: long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated and semi‑automated packaging lines.

Desirable qualifications

• Good communication and interpersonal skills.
• Good documentation skills, including legible handwriting.
• Basic computer and basic math skills.
• Knowledge of SOPs, specifications and job‑specific training materials.
• Familiarity with multiple types of packaging equipment and hand‑operated equipment such as barcode scanners, scales and tape guns.

Physical / Safety requirements

• Occasional (0‑33%): walking, climbing stairs/ladders, overhead reaching, lifting up to 38 lb, carrying up to 30 lb.
• Frequent (34‑66%): sitting, standing, reaching forward, object handling, fine hand coordination, lifting and carrying up to 32 lb, pushing/pulling up to 16 lb.
• Constant (67‑100%): object handling, fine hand coordination, simple hand grasping.
• Candidates must pass a post‑offer/pre‑employment job placement examination testing physical capabilities to perform essential functions.

Additional requirements

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

Benefits

• Day One Benefits – medical & dental coverage, flexible spending accounts, life and AD&D insurance, supplemental life insurance (spouse & child).
• 401(k) plan with company match.
• Time off program – paid holidays, paid time off, paid parental leave.
• Adoption reimbursement program, education assistance, employee assistance, community & volunteer service, employee ownership plan.
• Short‑ and long‑term disability insurance.
• Voluntary insurance – vision, accident, critical illness, hospital indemnity, identity theft protection, legal and more.
• On‑site campus amenities – workout facility, cafeteria, credit union.

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all duties and responsibilities. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Applications are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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