Senior Manufacturing Technician

Performs all tasks associated with preparing, formulating and dispensing aseptically manufactured products in and ISO 5 cleanroom environment according to cGMP Guidelines in order to meet production demands.

Schedule: Monday through Thursday 0500-1530. Weekend and off shift overtime as needed.

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and FDA regulations.
• Responsible for following detailed instructions and communicating effectively, both written and verbally.
• Perform Batch Record calculations and maintain all documentation according to cGMP Guidelines.
• Set up, maintain, and clean appropriate equipment and work area according to SOP and in compliance with cGMP guidelines.
• Set up, operate, and monitor production equipment and processes in accordance with current good manufacturing practices and standard operating procedures.
• Calibrate or adjust equipment to ensure quality production, using internal calibration functions.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
• 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.).

• Associate Degree preferred, High school diploma or equivalent required.
• Three or more years of relevant manufacturing experience required (regulated environment, attention to detail and following detailed instruction).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.
• Effectively adjusts to changes and deals effectively with uncertainties in the workplace.
• Ability to generate new and valuable ideas and effective solutions to difficult problems; connects previously unrelated notions.
• Realizing the worth of all people and respects others, regardless of background or cultural differences.
• Thoroughly understanding the needs of internal/external customers and making customer satisfaction a top priority.
• Strong motivation and ability to achieve work goals and quantifiable business results.
• Ability and desire to cooperate, collaborate, and partner with others.
• Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
• Has demonstrated the use of logical methods to solve problems with effective solutions and able to make quick quality decisions.
• Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
• Takes ownership and accountability for the production process, assigned production area, production equipment and associated documentation.
• Good interpersonal skills and ability to communicate information in a timely manner to those who need the information.
• Drive self and team to schedule adherence and most efficient production process.
  
  

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) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• 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.