Sterile Packaging Operator I Job at KVK Tech, Langhorne, PA

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  • KVK Tech
  • Langhorne, PA

Job Description

Job Description

Job Description

Aseptic Packaging Operator I

 

About Penn Life Sciences
Penn Life Sciences is a growing sterile injectable pharmaceutical manufacturer dedicated to delivering high-quality medicines that improve patient lives. We are seeking motivated individuals to join our Packaging team and support our mission of excellence in sterile manufacturing.

Position Overview
As an Aseptic Packaging Operator I , you will be responsible for packaging sterile pharmaceutical products in a cleanroom environment while maintaining strict compliance with cGMP and aseptic standards. This entry-level position offers hands-on training and development in aseptic manufacturing, making it an excellent opportunity to grow a career in the pharmaceutical industry.

Key Responsibilities

  • Operate and monitor aseptic packaging equipment according to SOPs.

  • Perform visual inspections of filled and sealed units to ensure packaging integrity.

  • Complete accurate batch records, logbooks, and in-process documentation in compliance with data integrity requirements.

  • Clean and sanitize equipment, components, and work areas following aseptic and environmental protocols.

  • Follow strict gowning and aseptic techniques while working in controlled cleanroom environments.

  • Report deviations, equipment malfunctions, or abnormal conditions promptly to supervision.

  • Assist with line clearances, changeovers, and preparation for production runs.

  • Collaborate with team members to achieve production and quality goals.

Qualifications

  • High School diploma or equivalent required.

  • 0–1 year of experience in pharmaceutical packaging, aseptic manufacturing, or another regulated production environment preferred.

  • Ability to read and comprehend SOPs, batch records, and training materials.

  • Strong attention to detail and ability to identify visible defects.

  • Effective verbal and written communication skills.

Physical Demands

  • Ability to stand for extended periods during aseptic packaging and inspection activities.

  • Ability to walk, bend, crouch, and reach regularly to operate equipment and handle sterile components.

  • Ability to lift and carry up to 25 pounds.

  • Ability to perform repetitive manual tasks requiring dexterity and sustained hand use.

  • Ability to don, doff, and work in full aseptic gowning (including coveralls, gloves, masks, goggles, and hoods) for extended periods in classified cleanroom environments.

  • Ability to maintain visual acuity (close vision, distance vision, color vision, depth perception) for inspection of sterile units.

Work Environment

This role is performed in controlled cleanroom environments requiring aseptic gowning and strict compliance with environmental and safety standards. Employees must be able to work under sterile conditions, adhere to gowning and PPE requirements, and perform effectively in a regulated pharmaceutical manufacturing setting.

Why Join Penn Life Sciences?

  • Be part of a growing pharmaceutical company dedicated to patient health.

  • Hands-on training and professional development in aseptic operations.

  • Opportunity to build a long-term career in sterile injectable manufacturing.

  • Collaborative, team-oriented culture focused on quality and compliance.

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