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Summary of Position
The role of a Senior Manufacturing Technician is to perform all tasks associated with operating equipment through formulation, preparation, dispensing and packaging of aseptically filled radiopharmaceutical processes, according to cGMP guidelines to meet production demands. The Senior Manufacturing Technician will work with advanced automated equipment, in the creation of new products, and serve as one of several technicians while coordinating work in accordance with standard operating procedures (SOP’s).
Essential Functions
- Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP’s as well as US and international regulations (i.e. FDA, HC, EU, TGA, etc.).
- Perform and document tasks associated with the production of radiopharmaceuticals in accordance with Federal and/or State guidelines in a cGMP environment.
- Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the area.
- This position will coordinate with Staging, Warehouse, Label Control, and Production Supervisors to plan, schedule, and execute all aspects of the area.
- Monitor and inspect product quality to ensure compliance with standards and specifications.
- Must pass Visual Acuity, Color Vision Test and Respiratory Test as required for process needs.
- Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
- Perform Batch Record calculations, reviews and maintain all documentation according to cGMP Guidelines.
- Follow detailed instructions and communicate effectively, both written and verbally.
- Set up, operate, monitor, and clean production equipment and processes in accordance with current good manufacturing practices and standard operating procedures.
- Ensures the maintenance and cleanliness of department, premises, and equipment.
- Order and maintain inventory of materials and supplies.
- Act as demonstrators and/or qualifiers for processes and procedures during the training of new employees.
- Troubleshoot problems with equipment, devices, or products.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Works with leadership to improve operations.
- Must be willing to attend additional training when required.
- Demonstrates willingness to be flexible to the needs of the department and business, including outside of the department.
- Takes ownership and is an active member with continuous improvement activities including: reliability team meetings, root cause analysis, SOP and Batch record improvements, Kaizen events, and Customer Complaints.
Requirements
- High School Diploma or equivalent required.
- 3+ years of relevant work experience is required, preferably in a pharmaceutical or manufacturing industry.
- Proven high performer capable of meeting or exceeding goals on time as well as meeting objectives of the team.
- Exemplary team building behavior and a proven collaborative attitude.
- Experience working in an FDA-regulated cGMP environment is preferred.
- Must be capable of providing front line troubleshooting of manufacturing equipment and process issues, properly elevating concerns, and issues to appropriate personnel.
- Willingness to work rotating shifts, weekends, and overtime, as necessary.
Schedule: Rotating Schedule 10 Hour – W1 Su-W 5:00pm – 3:30am, W2 Sa-M & W 5:00pm – 3:30am, W3 Sa-T 5:00pm – 3:30am. Ability to work overtime when necessary.
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