Asepsis, Autoclave, Biology, Change Control, Cleanroom, Continuous Improvement, Corrective Action, Current Good Manufacturing Practice (cGMP), Data Quality, Documentation, Documentation Review, Drug Manufacturing, Drug Products, Equipment Validation, GMP (Good Manufacturing Practices), Identify Issues, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Manufacturing/Industrial Processes, Operational Support, Patient Safety, Product Support, Quality Control, Quality Management, Regulatory Compliance, Safety Compliance, Safety/Work Safety, Technical Support
Pay Range: $27 to $30/Hour on W2
Training will be Monday to Friday 7am 3:30pm (Roughly two to three months). After training the schedule will be 2-2-3 schedule. 2-2-3 starts at 7am and end at 7pm.
Drug Product organization supports sterile pharmaceutical manufacturing operations including visual inspection, formulation support, aseptic processing, and related GMP activities. Colleagues work in a highly regulated cGMP environment focused on quality, compliance, patient safety, and operational excellence.
Purpose:
Performs all Band 1 responsibilities and independently executes sterile manufacturing operations, including Formulation, Filtration, and Aseptic Filling. Applies technical expertise to support safe, compliant, and efficient production.
Responsibilities:
Perform all responsibilities of Formulation Technician I.Execute material handling, line clearance, equipment preparation, and manufacturing support activities.
Execute sterile filtration, aseptic filling, and related manufacturing operations according to approved procedures.
Operate, monitor, and troubleshoot manufacturing equipment and automated systems.
Perform activities including weight and dispense, solution preparation, autoclave operations, visual inspection, material transactions, and manufacturing support functions.
Ensure compliance with cGMP requirements, Good Documentation Practices, and data integrity standards.
Monitor manufacturing processes and identify opportunities to improve safety, quality, and efficiency.
Support investigations, deviations, change controls, and corrective actions as required.
Assist with equipment qualification, validation, and continuous improvement initiatives.
Cross-train across multiple manufacturing areas to support operational flexibility.
Education:
Associate degree or Bachelor's degree in Life Sciences, Engineering, or a related field PREFERRED. Will consider applicants with experience in lieu of a degree.
Relevant GMP manufacturing experience preferred.
Experience:
2+ years GMP manufacturing or related technical experience.
Knowledge Skills, and Abilities:
Working knowledge of GMP manufacturing operations
Ability to operate and troubleshoot manufacturing equipment
Strong documentation and problem-solving skills
Ability to support multiple manufacturing processes
Physical Environment:
Routine presence in GMP manufacturing and controlled cleanroom environments.
Required use of personal protective equipment (PPE).
Ability to gown and work in classified manufacturing areas in accordance with site procedures.
Frequent standing, walking, bending, and computer-based work.
Ability to lift up to 25 pounds occasionally.
Visual acuity sufficient to review documentation and perform quality inspections.
Ability to support operations during non-standard hours as business needs require.
I
Integrated Resources, Inc