Entry Level: BioTech

Aliquoting bench volumes

Simulation vetted by professionals from CMDOs in the Greater St. Louis Region

Industry job title:

Packaging Technician I

Associated Simulation Library:

Background

Packaging technicians at Contract Development and Manufacturing Organizations (CDMOs) in the pharmaceutical industry are responsible for packaging pharmaceutical products according to 

specific guidelines and regulations. They ensure that products are packaged accurately, safely, and in compliance with regulatory standards.

Their duties typically include:

(expand each entry for a full definition of responsibilities and expectations)

  • They set up and operate packaging equipment such as labeling machines, blister packaging machines, bottle fillers, and cartoners. This involves configuring machines according to product specifications, ensuring proper alignment, and performing equipment checks to ensure functionality.

  • Packaging technicians perform visual inspections and quality checks on packaged products to ensure they meet regulatory requirements and quality standards. This may include checking for proper labeling, verifying batch numbers and expiration dates, and inspecting packaging integrity.

  • Packaging technicians wearing PPE will handle packaging materials such as bottles, blister packs, labels, and cartons. They ensure that materials are stored properly, handled safely, and used efficiently to minimize waste. *Technicians may need to handle large volumes and weights. For example, materials may arrive in 50 gallon drums that can weigh up to 150kg. 

    • If packing down 50kg into 10g volumes, the product will be weighed using a spatula, and aliquot into bottles and capped with a security seal.

    • If packing down into 500g volumes, the product will be weighed using a smaller scoop, and aliquot into bottles and capped with a security seal.

    • If packing down 150kg drums into 10kg volumes, the product will be weighed using floor scales, hand scoops and aliquot into buckets using double liners, tie bag, and screw lid.

  • Packaging technicians follow safety protocols and procedures to minimize the risk of accidents and injuries.

  • Following safety protocols includes wearing appropriate personal protective equipment (PPE), handling hazardous materials safely, and reporting any safety concerns or incidents to supervisors. The employee will occasionally wear an air helmet, mask, safety shoes, apron rubber and Tyvek suits, protective gloves, safety glasses and goggles while performing in this position

  • They maintain accurate documentation of packaging activities, including batch records, packaging logs, and quality control reports. This documentation is essential for traceability, regulatory compliance, and batch release.

  • They are responsible for cleaning packaging equipment and work areas according to standard operating procedures (SOPs) and maintaining equipment in good working condition. Regular maintenance helps prevent equipment breakdowns and ensures smooth operations.

  • Packaging technicians adhere to regulatory requirements, including Good Manufacturing Practices (GMP), to ensure product safety and quality. This includes following standard operating procedures, maintaining cleanliness and hygiene standards, and participating in regulatory audits as needed.

  • They troubleshoot equipment malfunctions and process issues as they arise during packaging operations. This may involve identifying and resolving mechanical problems, adjusting machine settings, or consulting with maintenance personnel for assistance.

  • They collaborate with other team members, including operators, quality control personnel, and supervisors, to ensure efficient packaging operations. Effective communication and teamwork are essential for achieving production targets and meeting customer requirements.

The Process

  1. Look at the process order and master packaging formula (MPF)

    1. Review the safety information and PPE requirements

    2. Check the components needed for packaging

    3. Check the bulk material needed

    4. Read specific instructions for packaging

  2. Complete a line clearance form for the weighing environment. Line clearance is a standardized procedure in manufacturing for ensuring equipment and work areas are free of documents, and materials from a previous process. Line clearance procedures help operators prepare for the next scheduled process and avoid mislabeling or cross-contamination of finished products.

  3. Gather equipment needed and components from the MPF (could include a mechanical assist to open bags, scoops or spatulas)

  4. Perform the pack down from bulk

    1. While wearing PPE, hand weigh materials, fill and aliquot into smaller bottles according to the MPF, which specifies the quantity and sizes that need to be aliquoted

    2. Utilize a capping machine

    3. Record weights and info in the MBR or weighing documents

  5. Clean and label containers once pack down and fill is complete 

    1. Utilize a water-based method to wipe containers

  6. Move completed stock to packaging warehouse

  7. Turn in the completed paperwork to on-shift supervisor

  8. Perform clean up of room and equipment used

Resources

See the machinery used for filling, capping, and packaging products:

Learn about industry standards:

The Exercise

For this job sim, you are a packaging technician in the non-GMP packaging team. Although this is not a GMP environment, it is ISO9001. 

Your task is to take a 50lb bag of ammonium sulfate that weighs approximately 23 kilograms (kg) and turn into bench scale volumes of 5 grams (g) each. 

Important note - in this work environment, you will need to meet a daily quota that is tracked each day. Some companies may keep track of individual and/or team totals.

Task 1 - Look at the Process Order and Manufacturing Process Order

To start, read through a process order to familiarize yourself with the procedure. Process orders provide step-by-step instructions and real-time guidance for manufacturing a specific batch of product including equipment set-up, material handling, processing steps, and quality checks. Also includes documentation requirements and specific parameters for batch numbers, quantities, and dates.

This Process Order ensures that the repacking of ammonium sulfate from a 50 lb bag to 5 g packets is conducted systematically and adheres to quality standards.

Next, read through this Master Packaging Formula (MPF). MPFs specify the procedures for packaging a specific product, typically after the manufacturing process is complete.

Provides detailed instructions for packaging and labeling including setup, filling, sealing, and quality control checks. Pay attention to documentation requirements and storage instructions. Manufacturing and packaging technicians must follow an MPF to ensure a consistent and compliant packaging process.

A Process Order and a Master Packaging Formula (MPF) serve different purposes in manufacturing operations, particularly in pharmaceutical or chemical industries.

While both documents provide instructions for specific manufacturing tasks, a Process Order is focused on the actual production process, while a Master Packaging Formula is specific to the packaging and labeling of finished products.

Task 2 - Identify Your Safety Information

Identify your day to day wear before entering the environment- tyvek suit or lab coat; safety glasses, nitrile gloves, hair net and shoe covers; beard cover; respirator or air-fed hood (may be required). 

Use the MSDS to Identify the safety information for working with ammonium sulfate.

Task 3 - Execute a Weighing and Recording the MPF

For this job sim, you will use regular table salt, which is similar to ammonium sulfate, a different type of salt. Record your amounts in the batch record up to 2 decimals points (ex: 5.04 g). 

You will be given a container of salt, smaller bottles to fill, a scale, a spatula, and documentation (a process order and MPF). 

Perform basic volume calculations for gross, net, and tare weight. 

Net weight is the weight of the product, while gross weight is the weight of the product plus its packaging. Tare weight is the weight of the empty packaging.

Instructions: Weigh the product in its packaging to get the gross weight.

Remove the product from the packaging and weigh the packaging to get the tare weight.

Subtract the tare weight from the gross weight to get the net weight. 

Note that each chemical handles differently because of its chemical properties. It might be powdery like a baking soda or more solid like salt. Take care to handle each chemical appropriately. Read the SOP and SDS before working with any new chemicals.

Task 4 - Finalize the Pack Off

Deliverables

You will submit your batch record to your supervisor. You will also notify Quality by email that the pack down is complete and ready for their check.

Additional Tasks

A professional in the field of biomanufacturing may also perform these tasks:

  • Using palette jacks to move material around

  • Fork truck training; a company will certify you as a fork truck operator

  • Data entry at a later point (not necessarily for this role as a packaging technician)

Skills Used to Perform this Task

  • Attention to detail

  • Knowledge of lab safety

  • Accurate sample prep in a lab environment

  • Commitment to quality  

  • Basic computer skills and literacy

Skills Used in the Field

  • Technical skills - attention to detail, basic math, ability to read a balance

  • Handwriting and legibility

  • Interpersonal skills - work in a team environment with peers and management level employees, offer constructive feedback, communicate with other departments

  • Actively participates in company provided training and performs electronic training within the allocated time. 

  • Maintains a positive attitude, accepts constructive feedback, helps to identify problems and improvements.

  • Has a desire to learn, able to take direction.

  • Consistent attendance 

  • Accountability

Career Progression

Packaging technicians can progress from PT 1, PT 2, PT 3, and PT 4. Other options are manufacturing technician and GMP packaging, production set up roles, and leadership in the department

Sample Job Postings

Typical Pay Range $20-21/hr

Sirius Staffing

Chemical Packaging Technician | Pay rate: $20-23/hr


LanceSoft Inc.

Packaging Operator | Pay rate: $20-23/hr


Sigma-Aldrich

Packaging Technician | Pay rate: 24-36K/ annually


Gold Biotechnology

Weighing and Packaging Technician | Pay rate: $20-28/hr

Sample Job Posting: Packaging Technician

  • To stage, fill (manually or semi-automatically), cap, label and over pack liquid, powder and lyophilized products per approved packaging specifications while utilizing all required safety equipment. Complete appropriate packaging documentation per ISO procedures and deliver products to inventory. The employee will occasionally wear an air helmet, mask, safety shoes, apron rubber and Tyvek suits, protective gloves, safety glasses and goggles while performing in this position. You will also be standing for extended periods of time and repetitive movements throughout the shift.

    Responsibilities

  • To stage, fill (manually or semi-automatically), cap, label and over pack liquid, powder and lyophilized products per approved packaging specifications while utilizing all required safety equipment

  • Complete appropriate packaging documentation per ISO procedures and deliver products to inventory

  • The employee will occasionally wear an air helmet, mask, safety shoes, apron rubber and Tyvek suits, protective gloves, safety glasses and goggles while performing in this position

  • You will also be standing for extended periods of time and repetitive movements throughout the shift