Production Technician

Production Technician

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