Associate Manufacturing Technician

Singota Solutions•Bloomington, IN

1d•Onsite

About The Position

Why join Team Singota? We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that’s not just efficient, but also passionate, dedicated, and fun to work with. Job title: Associate Manufacturing Technician Department: Manufacturing Location: Bloomington, IN (Onsite) Position Type: Full-time, non- exempt Hours: 40 hr/wk, 1st shift General Description: Production operators actively participate in all the manufacturing operations for the company including: • Sampling/Dispensing • Drug product formulation • Aseptic filling • Finished dose labeling/kitting/packaging • Packaging Component Inspection (PCI) General: 1. Must be able to work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating procedures 2. Computer experience necessary. Proficiency with Microsoft Office (Outlook, Excel, Word). 3. Experience using equipment HMIs, as well as ERP or inventory systems desired 4. Attention to detail and good organization skills mandatory 5. Participate in and fully support process improvement initiatives 6. Ability to work in both collaborative and independent work situations and environments. 7. Must strictly adhere to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc. 8. Job requires gowning to work in cleanroom environments 9. Perform cleaning/disinfecting/sanitization of cleanrooms 10. Assist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operations 11. Ability to stand for a minimum of 4 hours 12. Must have good documentation practices with clear, legible handwriting 13. Provide recommendations and implement solutions to resolve equipment and/or process problems in a timely manner 14. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures 15. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business Sampling/Dispensing: 1. Pulling client material from warehouse for sampling and dispensing operations; putting client material away after operations complete 2. Sampling and dispensing client material from parent containers into smaller child containers 3. Working with hazardous and non-hazardous materials in a controlled environment and performing operations for short and long periods of time Formulation: 1. Precision weighing and measuring of buffers, excipients, API, etc. 2. Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipets 3. Ability to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testers Aseptic filling: 1. Install machine change parts and load recipes on fill machine 2. Staging/loading of components and preparation of fill path 3. Perform cleaning and VPHP decontamination of isolators 4. Assist with environmental monitoring Finishing (Labeling and Kitting): 1. Label and package filled drug product and/or pharmaceutical components per written specifications, SOP’s, job aids and batch records 2. Inspect product and printed materials for defects 3. Responsible for reconciliation of all controlled printed materials and product 4. Setup and operation of labeling and packaging equipment and systems 5. Preparation and use of precision measuring instruments

Requirements

Excellent work ethic and attention to detail.
Requires repetitive hand, wrist, arm motions.
Hand eye coordination and manual dexterity with small components.
Use of small tools and laboratory/production equipment.
Clear, legible handwriting.
Able to comprehend and execute complex written instructions.
Must be able to lift, push, or pull up to 50 pounds.
High school diploma with 0-1 years industry experience OR Associates Degree in an Engineering or Science discipline with minimum 1 year industry experience OR Bachelors Degree in an Engineering or Science discipline.

Nice To Haves

Experience using equipment HMIs, as well as ERP or inventory systems desired.

Responsibilities

Actively participate in all manufacturing operations including Sampling/Dispensing, Drug product formulation, Aseptic filling, Finished dose labeling/kitting/packaging, and Packaging Component Inspection (PCI).
Work within an FDA regulated environment per 21CFR 210/211 requirements and internal policies/SOPs.
Use computer systems, including Microsoft Office (Outlook, Excel, Word).
Experience using equipment HMIs, ERP or inventory systems is desired.
Maintain attention to detail and good organization skills.
Participate in and support process improvement initiatives.
Work effectively in both collaborative and independent situations.
Adhere to all safety requirements, including wearing proper PPE (respirator, safety glasses, gloves, etc.).
Gown to work in cleanroom environments.
Perform cleaning, disinfecting, and sanitization of cleanrooms.
Assist in process investigations, writing deviations, and implementing CAPAs.
Stand for a minimum of 4 hours.
Maintain good documentation practices with clear, legible handwriting.
Provide recommendations and implement solutions for equipment and/or process problems.
Comply with quality and safety management systems, including documentation, training, system use, SOPs, processes, and procedures.
Perform multiple tasks both inside and outside the department to meet business needs.
Pull client material from the warehouse for sampling and dispensing operations and put it away after operations complete.
Sample and dispense client material from parent containers into smaller child containers.
Work with hazardous and non-hazardous materials in a controlled environment.
Perform precision weighing and measuring of buffers, excipients, API, etc.
Use basic lab instruments (pH meter, conductivity meter, pipets).
Use basic manufacturing equipment (biosafety cabinets, mixers, pumps, filter testers).
Install machine change parts and load recipes on the fill machine.
Stage/load components and prepare the fill path.
Perform cleaning and VPHP decontamination of isolators.
Assist with environmental monitoring.
Label and package filled drug product and/or pharmaceutical components per specifications, SOPs, job aids, and batch records.
Inspect product and printed materials for defects.
Reconcile all controlled printed materials and product.
Set up and operate labeling and packaging equipment and systems.
Prepare and use precision measuring instruments.