Senior Manufacturing Technician

Senior Manufacturing Technician

Location:

Maryland Heights, MO.

Work schedule:

Monday – Thursday 6am – 4:30pm. Overtime may be required. Hours may change to meet operational needs.

The role of a Senior Manufacturing Technician is to operate equipment for aseptic fill radiopharmaceutical processes in accordance with cGMP guidelines to meet production demands. The Senior Manufacturing Technician will work with advanced automated equipment, contribute to new product creation, and serve as one of several lead technicians while coordinating work in accordance with standard operating procedures (SOPs).

• Provide directional leadership on the production floor.
• Maintain operational compliance with U.S. and international regulatory agencies (FDA, EU, TGA, PIC/S, ISO, USP, NPI, etc.).
• Follow quality, safety, and regulatory guidance and written procedures.
• Actively participate in continuous improvement initiatives.
• Ensure the maintenance, cleanliness, and performance of department premises and equipment.
• Perform documentation in accordance with cGMP guidelines.
• Properly review Batch Records.
• Work with the team to foster a team environment.
• Follow all written procedures and verbal instructions.
• Communicate effectively through written or spoken instructions.
• Taking full ownership and accountability of the process.
• Collaborate with the coordinator to resolve challenges.
• Collaborate with leadership to improve operations.
• Willing to attend additional training or schooling when required.
• Ensure internal and external customer expectations are met or exceeded.
• Adjust to changes and handle uncertainty effectively.
• Drive to achieve work goals and quantifiable business results.
• Demonstrate a flexible attitude for business success.
• Demonstrate willingness to be flexible to the needs of the department and business.

• Associate Degree or equivalent technical or vocational certification. Relevant years of experience may be considered.
• Three or more years of relevant work experience, preferably in a pharmaceutical or manufacturing industry.
• Experience working in an FDA-regulated cGMP environment is preferred.
• Strong mechanical aptitude and scientific background preferred.
• Capable of front-line troubleshooting of manufacturing equipment and process issues, properly elevating concerns to appropriate personnel.

• Willingness to work in a plant producing radioactive materials and participate in safety programs designed to minimize potential or actual exposure levels.
• Physical requirements:
  
  lift up to 70 pounds, kneel, crouch, twist upper body, walk, bend, stoop, push, pull, reach, negotiate stairs and evacuation ladders, wear PPE, enter vessels, and inspect equipment. Must be able to stand or sit for long periods of 8+ hours a day.
• Use of material handling devices (hand truck, fork lift, conveyors) is expected. Proper lifting techniques necessary to prevent injury.
• Willingness to wear a variety of PPE and hearing protection as needed.
• Must possess good hand‑eye coordination; attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted time frames 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.

Mid‑Senior level

Full‑time

Manufacturing

Biotechnology Research, Medical Equipment Manufacturing, Pharmaceutical Manufacturing