SMO- Penicillin Sterile Manufacturing Operator; 2nd shift

Role Summary

Penicillin Sterile Manufacturing Operator (2nd shift: 3:00 p.m. – 11:30 p.m.) in a Penicillin Facility. You will perform packaging and inspection tasks, support manufacturing operations, and ensure compliance with cGMP and safety standards. This role requires collaboration with supervisors and cross-functional teams to maintain production schedules and quality.

• Performs all tasks as outlined in the Batch Card, SOPs, and/or Job Aids.
• Effectively demonstrates and understands the SOPs and Job Aids pertinent to all assigned tasks.
• Inspects filled syringes to established criteria and sorts defects into the appropriate receptacle for reconciliation.
• Performs manual packaging operations as assigned by the supervisor according to the appropriate SOP or Job Aid.
• Observes all SOPs and Safety and Health Regulations.
• Re-stocks packaging supplies from line stock as required to maintain packaging operation.
• Notifies supervisor, PMO and/or Quality Specialist of unusual or recurring defects in syringe products or packaging materials.
• Maintains work area in a clean and orderly manner.
• Assists in training new colleagues as required.
• If required, verifies packaging supplies and product against product board or Batch Card to assure correctness.
• Signs pertinent forms as required.
• Participates in all required training programs to maintain required level of cGMP compliance.
• Performs off-line inspection of product, such as media reading, as required.
• Performs other miscellaneous duties as assigned by supervisor.

• Required:
  
  High School Diploma or GED with 2+ years of experience
• Required:
  
  Understanding basic problem-solving methods, mathematics, and reading skills
• Required:
  
  Good Manufacturing Practices (also cGMP) and Batch Record comprehension
• Required:
  
  Strong communication and leadership skills
• Required:
  
  Ability to contribute to department success in a team environment
• Required:
  
  Performing tasks at a productive level under demanding conditions
• Required:
  
  Solid understanding of procedures, techniques, tools, materials, and equipment
• Preferred:
  Experience in a pharmaceutical or manufacturing environment
• Preferred:
  Proficiency in engineering software and tools
• Preferred:
  Knowledge of regulatory requirements and quality standards
• Preferred:
  Strong analytical and problem-solving skills
• Preferred:
  Excellent organizational and time management skills
• Preferred:
  Demonstrated ability to prioritize tasks and manage multiple projects simultaneously
• Preferred:
  Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

• Communication
• Team collaboration
• Problem-solving
• Attention to detail
• Time management
• Analytical thinking

• High School Diploma or GED

• This position is in a Penicillin Facility. The candidate cannot be allergic to Penicillin, and will be required to undergo Penicillin allergy testing.
• The department requires bending, reaching, lifting, and standing for extended periods.
• Ability to grasp 4–5 filled syringes at a time in one hand while manipulating them with the other hand for defect evaluation.
• Corrected 20/20 vision and ability to pass routine inspection tests using seeded syringes.
• Shift pace may require extended hours and six to seven days of operation; overtime may be required to maintain delivery schedules.