Manufacturing Technician

Summary of Position

The role of a Manufacturing Technician, located at our Noblesville, Indiana facility, is to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands. The Manufacturing Technician will have knowledge of the manufacturing process and serve as one of several technicians while coordinating work within the standard operating procedures (SOP’s).

Work Schedule: Friday through Tuesday, 2nd shift 4pm – 12:30am OR Saturday through Wednesday 3rd shift 12am – 8:30am. Schedule could be adjusted. Ability to work overtime when necessary.

Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Ensure strict adherence to quality, safety, regulatory, and written procedures in the manufacture of products in accordance with OSHA and CFR (cGMP) guidelines.
• Handling of radioactive materials with strict adherence to ALARA principles and dosimetry monitoring.
• Aseptic technique under radioactive constraints – clean room and hot cell / isolator environments (remote tools, lead glass visibility, integrated gloves and/or tele manipulators).
• Ensure vigilance to the production schedule to meet customer demands and reduce overtime (ensure most effective and efficient use of personnel, materials, and time).
• Execute aseptic manufacturing, in-process controls, and documentation activities in accordance with cGMP requirements and within critical timeframes dictated by the radioactive decay of short-half-life isotopes.
• 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.
• Ensure the maintenance and cleanliness of department, premises, and equipment.
• Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines. Review documentation, make corrections, and sign off as required by SOPs and cGMP Guidelines.
• Monitor product quality to ensure compliance with standards and specifications.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
• Inspect in-process and finished products for quality and adherence to customer specifications.
• Ability to identify and verify appropriate materials, area conditions, process for production and address any abnormalities in the process, with materials or in area conditions in collaboration with Quality and leadership.
• Take full ownership and accountability of equipment, process, and area assigned to or related to production process.
• Use logical methods to solve difficult problems with effective solutions and is able to make sound decisions in a timely manner, sometimes with incomplete information, and under tight deadlines and pressure; able to make a quick quality decision.
• Must be willing to attend additional training/schooling when required.

Requirements

• High school diploma or GED equivalent is required. Associate degree is preferred.
• One or more years of relevant work experience in manufacturing required (regulated environment, attention to detail, and following detailed instructions).
• Experience with radiopharmaceuticals preferred.
• 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.
• Strong mechanical aptitude as well as scientific background.
• Able to provide front line troubleshooting of equipment/process issues.
• Thorough understanding of the needs of internal/external customers and ensuring customer satisfaction a top priority.
• Capable of adjusting to changes and dealing effectively with uncertainties in the workplace.
• Experience generating new and valuable ideas and effective solutions to difficult problems; connecting previously unrelated notions.
• Strong motivation and ability to achieve work goals and quantifiable business results.
• Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
• Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
• Knowledge of Good Manufacturing Practices c(GMP)’s and applicable Quality System Standards.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including powered air purifying respirator (PAPR) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties and donning appropriate PPE.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.