Production Technician
West Deptford, NJ, US
 
Role Overview:
 The Production Technician will manufacture of bulk API pharmaceuticals in accordance with customer and internal specifications.
Core Responsibilities: 

• Complete batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines 
  

• Provide process support and troubleshooting necessary to meet all customer requirements 
  

• Maintain the facility in excellent FDA/cGMP posture
  

• Responsible for safety equipment and active participation in safety program and hazard analysis. Wears appropriate PPE for task. 
  

• Ensure that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
  

• Assure all production/support equipment is in proper operating condition and that all production equipment is appropriately labelled with a current status tag. Works collaboratively with Maintenance, as appropriate.
  

• Ensure the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations. 
  

• Ensure a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas. 
  

• Active member of Emergency Response Team. Participate in Emergency Response Training and related activities. 
  

• Promote a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations. 
  

• Provide prompt, appropriate feedback to team members, both positive and constructive, in a continuing effort to develop employees to their full potential. 
  

• Demonstrate a professional and positive attitude, integrity and a strong work ethic and encourages team members to do the same. 
  

• Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
  

• Operate machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions. 
  

• Basic batch processing and unit operations, able to run all milling operations. 
  

• Thinking is within well-defined procedures with assistance readily available.
  

• Proficient in all tasks/unit operations associated with a processing area
  

• Able to complete basic mechanical work required to keep operation moving
  

• Complex batch processing and unit operations, such as hydrogenations, PFD operations etc. 
  

• Resolve regular technical problems and takes action to ensure the production plan continues to move

 
Qualifications: 
Required

• High School Diploma with 5-7 years of experience in an API Manufacturing facility or AA in Chemistry, Engineering, or other related technical field with 3-5 years of experience or BS in Chemistry, Engineering or other related technical field 
  

• Solid understanding of GMP and FDA 
  

• Safety Awareness 
  

• Authenticity and motivation to contribute to team success 
  

• Ability to independently apply scientific and/or technical knowledge in the performance of job duties
  

• Commitment to continuous learning and improvement
  

• Effective written and verbal communication

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