Aseptic Technician, Lead
Durham, NC, US, 27703
Job title: Aseptic Technician III
Location: Durham/ Lillington
About Us
Ingersoll Rand is a Fortune 500 company with a passion for making lives better. We do this by living our values, and through a relentless focus on the success of our customers and partnering with our employees to think and act like owners. We believe in sustainability through the development and distribution of a broad range of global brands designed to meet the needs of our customers in both efficient and responsible ways. Ingersoll Rand is a diverse and inclusive environment. For more information visit: www.irco.com.
Job Overview:
As an Aseptic Technician III, you will be responsible for performing various tasks related to the aseptic filling of pharmaceutical products in ISO class 7 rooms with ISO 4 and 5 filling hood systems. You will work closely with other members of the production team to ensure that all products are manufactured in accordance with established GMP guidelines and meet the company's high standards of quality, safety, and efficacy.
An Aseptic Technician III works under minimal supervision with latitude for independent judgement.
This role will train level I and II Technicians on all systems in the manufacturing of pharmaceutical products.
This is an on-site floor support position. Typical hours are 8 am – 4:30 pm M – F.
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Responsibilities:
- Perform aseptic filling of pharmaceutical products using ISO class 7 clean rooms with ISO 4 and 5 filling hood systems that are moderately complex in nature.
- Formulate and mix pharmaceutical products in accordance with established protocols.
- Operate equipment, including filling machines, autoclaves, and sterilizers, according to established protocols and SOP’s.
- Will perform a variety of processing duties according to the Batch Production Records (BPRs) and Standard Operation Procedures (SOPs) in the Manufacturing Department including, but not limited to the cleaning / recovery of classified area and workspaces, components preparation, weighing of the raw materials, compounding/formulation, filtration of solutions, aseptic filling, inspection, labeling and packaging.
- Prepare the clean room (materials, resources, etc.) with the aim of eliminating any errors and to work according to Current Good Manufacturing Practices (cGMP).
- Perform dry repackaging of pharmaceutical products in accordance with established procedures.
- Monitor and maintain aseptic conditions in the filling room, including cleaning and disinfecting equipment and surfaces.
- Follow all safety procedures and guidelines, including wearing appropriate personal protective equipment (PPE).
- Complete all necessary documentation and records, including batch records and logbooks, according to GMP guidelines.
- Participate in training programs to maintain and improve skills and knowledge of aseptic techniques and procedures.
- Performs all other duties as assigned by supervisor / management.
Requirements:
- High school diploma or equivalent required.
- 5 years’ experience in a clean room environment performing liquid injectable Aseptic filling / finishing
- Experience using Microsoft Office Suite.
- Experience with GMP and aseptic techniques
- Experience with general safety and hygiene practices.
Core Competencies:
- Operating knowledge of Microsoft office software and other basic computer usage. Working proficiency with hand held computer (i.e. Smartphone, iPad) and network bases.
Preferences:
- Ability to follow and understand written procedures and protocols.
- Excellent attention to detail and ability to complete accurate documentation.
- Ability to work in a fast-paced, team-oriented environment while maintaining a high level of quality and safety.
- Demonstrates strong analytical, problem-solving skills.
- Strong written and verbal communication skills.
- Associates degree in technical field.
- Experience in the Pharmaceutical/Medical Device Industry strongly preferred
- Mechanically inclined with troubleshooting aptitude.
- BioWork Aseptic Certification Strongly Preferred
Travel & Work Arrangements/Requirements
This position will be based at our corporate offices in Durham and Lillington, NC.
What we Offer
At Ingersoll Rand, we embrace a culture of personal ownership — taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond.
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Nearest Major Market: Durham
Nearest Secondary Market: Raleigh