Position: Manufacturing Technician – Sterile Injectable Operations

Location: Morrisville, NC
Pay Rate: Up to $35/hour (based on experience)

Overview:

A fast-paced, regulated manufacturing site is seeking an experienced Manufacturing Technician to support sterile injectable operations. This role involves hands-on aseptic processing, equipment setup and maintenance, and participation in process improvements within a GMP-compliant environment. The ideal candidate will have a background in sterile pharmaceutical manufacturing, strong attention to detail, and the ability to operate with minimal supervision in a cleanroom setting.

Key Responsibilities:

• Perform sterile production operations including material handling, compounding, aseptic filling, lyophilization, capping, and visual inspection under strict GMP and safety protocols.

  
  

• Lead or assist with equipment setup, troubleshooting, preventative maintenance, and cleaning validation.

  
  

• Execute batch records, SOPs, and controlled documentation with a focus on accuracy, compliance, and right-first-time execution.

  
  

• Serve as a technical SME for aseptic processes and provide mentorship or training to team members as needed.

  
  

• Support cross-functional teams in equipment qualification, process validation, and deviation investigations.

  
  

• Participate in routine sampling, in-process checks, and quality inspections to ensure product meets required specifications.

  
  

• Perform routine room and equipment cleaning/sanitation in accordance with environmental monitoring and contamination control standards.

  
  

• Collaborate with QA, Engineering, and Technical Operations to identify and implement process improvements.

  
  

• Take part in shift handovers, daily huddles, and safety discussions to ensure smooth operation and knowledge transfer.

Qualifications:

• High school diploma or GED required; Associate or Bachelor’s degree in a scientific or technical discipline preferred.

  
  

• Minimum 5 years of experience in GMP manufacturing, preferably with expertise in sterile/aseptic processing or biologics production.

  
  

• Strong working knowledge of cleanroom protocols, gowning, aseptic technique, and contamination control.

  
  

• Experience with at least some of the following technologies: autoclave prep, vial washing, compounding, isolator filling, lyophilization, visual inspection, or documentation review.

  
  

• Ability to interpret batch records and SOPs; experience suggesting or implementing procedural improvements is a plus.

  
  

• Effective communication and leadership skills; prior experience training or mentoring peers preferred.

  
  

• Capable of lifting up to 30 lbs and wearing full PPE, including respirators, when required.

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