GE HealthCare Pharma Manufacturing Technician 

United States, Illinois 

224891417

Responsibilities-

Key Responsibilities/Essential Functions Include:

• Process, assemble, dispense, assay and package radio chemicals, radiopharmaceuticals or radioactive devices in accordance with established procedures.
• Knowledge of all preparations and manufacturing procedures for the formulation of final product.
• Assists in training and development of other technicians.
• Accurately review and complete all batch records and related documentation.
• Preparation and set-up of associated equipment and materials, i.e. Depyrogenation Ovens, ISO5 Hoods, autoclaves, etc.
• Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSR?s) and Personal Protective Equipment (PPE) requirements.
• Strict adherence to cGMP at all times.
• Perform housekeeping in accordance with 5S policy perform Preventative Maintenance (PM) as required.
• Troubleshoot basic equipment problems by communicating with the Lead Technician.
• Assist in writing Investigation Reports (IR?s) and initiate Unscheduled Work Orders (UWO?s).
• Utilize Trackwise program to document maintenance, investigations, and change control actions. Utilize Veeva document management system to manage web-controlled documents.
• Ability to pass all gown qualifications is required for employees who need to perform work in the dilution and filling suite

Qualifications-

Quality Specific Goals:1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required

Required Qualifications: (outline the minimum requirements)

1. Associate's degree plus a minimum of 3 years experience working in a cGMP manufacturing environment or High School diploma/GED equivalent plus a minimum of 4 years experience working in a cGMP manufacturing environment.
2. Basic computer/data entry skills.
3. Strong mathematical aptitude including Algebra and Geometry.
4. Must understand oral/written technical English (or local language).
5. Must perform shift/weekend work.
6. Must be able to lift 35 lbs or more.
Preferred Qualifications:
1. Bachelor's degree plus 2 years experience working in a cGMP manufacturing environment.
2. Experience working with radioactive materials and/or radioactive isotopes.
3. Experience working with Access database programs and manufacturing equipment such as ion chambers, autoclaves, de-pyrogen ovens, automated counters, micro welders, forklifts and semi-automated equipment.
4. Previous experience in roles requiring strong attention to detail.
5. Strong technical writing ability.
6. Ability to multi-task.