Aseptic Technician, Level II
Job Title: Aseptic Technician II
Reports to: Associate Production Manager
ILC Dover is a world leader in the innovative design and production of engineered products employing high-performance flexible materials. Since 1947, we have provided engineered solutions to complex customer problems. Initially known for the production of space suits for NASA, we leverage our vast materials, engineering, process, and design experience to create high performance systems for a wide range of industries. ILC Dover is a portfolio company of New Mountain Capital, which acquired the company in February 2020.
Recognized globally for our flexible containment solutions, ILC Dover serves customers in a diverse range of industries, including pharmaceutical and biopharmaceutical manufacturing, personal care, food and beverage, chemical, aerospace, healthcare and government agencies. ILC Dover’s visionary solutions improve efficiency, safeguard workers and product, and prevent disasters. For more information visit ILCDover.com and follow us on LinkedIn.
As an Aseptic Technician II, 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.
Successful candidates will have cGMP experience in pharmaceutical and/or medical device manufacturing environments, a data driven approach, and a willingness to work together as a team.
This is an on-site floor support position. Typical hours are 6:00 am – 5:00 pm M – Th.
*Essential Job Duties:
- 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.
- Good understanding of GMP and aseptic techniques.
- 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 environment while maintaining a high level of quality and safety.
- Works under moderate supervision with some latitude for independent judgement.
- Performs all other duties as assigned by supervisor / management.
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Must be able to access shared database with government programs (U.S. Citizen or Permanent Resident of the U.S.).
- High School Diploma and 2-3 years of relevant experience.
- Proficient in using Microsoft Office Suite.
- Experience with liquid injectable Aseptic filling / finishing.
- Demonstrates strong analytical, problem-solving skills.
- Strong written and verbal communication skills.
- Detail oriented, good organizational traits.
- Knowledge of general safety and hygiene practices.
- Ability to work in a team-oriented environment.
- Bachelor’s or advanced degree in Engineering and or related field.
- Experience or exposure to the Pharmaceutical/Medical Device Industry.
- Experience in a clean room environment and aseptic manufacturing environment.
- Mechanically inclined with troubleshooting aptitude.
- Aseptic Certified
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Color vision, Distance vision and Depth perception. While performing the duties of this Job, the employee is regularly required to walk and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; stoop, kneel, crouch, or crawl and taste or smell.
As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.
Background Check & Drug Screening Required
EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran