Senior Manufacturing Technician

Position: **Senior Manufacturing Technician** 29-30/HR
Location: Maryland Heights

Lead Manufacturing Technician

Job Description

The Lead Manufacturing Technician operates advanced automated equipment to support the formulation, preparation, and dispensing of pharmaceutical products in accordance with cGMP guidelines. This role serves as a lead technician on the production floor, coordinating work activities, reviewing documentation, and ensuring that all processes comply with standard operating procedures (SOPs). The technician contributes directly to the production of life-saving diagnostic drug products and plays a key role in maintaining high-quality, compliant manufacturing operations.

Responsibilities

+ Operate advanced automated equipment to perform formulation, preparation, and dispensing of pharmaceutical products in compliance with cGMP guidelines.

+ Execute all manufacturing tasks in accordance with standard operating procedures (SOPs) and established production processes.

+ Perform accurate and timely documentation of all manufacturing activities in line with cGMP requirements.

+ Properly review batch records to ensure completeness, accuracy, and compliance with regulatory and internal quality standards.

+ Provide leadership on the production floor by coordinating work among technicians and supporting daily production priorities.

+ Assist in the creation and manufacture of new products by following defined processes and operating specialized equipment.

+ Provide front-line troubleshooting of manufacturing equipment and process issues, and escalate concerns to appropriate personnel when necessary.

+ Follow cleanroom procedures and aseptic techniques to maintain a sterile production environment.

+ Support packaging and production operations as needed to meet production demands and schedules.

+ Adhere to all safety procedures, including those related to working with radioactive materials and advanced equipment.

+ Participate actively in safety programs designed to minimize potential and actual exposure levels.

+ Maintain close attention to detail to ensure product quality, accurate documentation, and compliance with regulatory requirements.

+ Collaborate with team members in a team-based environment to achieve production goals and continuous improvement objectives.

+ Perform physical tasks such as lifting, walking, bending, stooping, pushing, pulling, reaching, and climbing stairs as required to complete production activities.

+ Handle radioactive cyclotron components frequently and use personal protective equipment as required by procedures.

+ Work rotating schedules and outside regular work hours as needed to support continuous production operations.

Essential Skills

+ Three to five 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 with the ability to understand and operate advanced automated manufacturing equipment.

+ Demonstrated ability to perform documentation in accordance with cGMP guidelines.

+ Experience reviewing batch records for completeness, accuracy, and compliance.

+ Capability to provide front-line troubleshooting of manufacturing equipment and process issues.

+ Ability to properly elevate equipment and process concerns to appropriate personnel.

+ Familiarity with cleanroom operations and sterile production environments.

+ Strong attention to detail and commitment to quality and compliance.

+ Good hand-eye coordination to safely and accurately operate equipment and handle components.

+ Willingness and ability to work rotating schedules and outside regular work hours.

+ Ability to perform physical activities such as lifting up to 70 lbs, walking, bending, stooping, pushing, pulling, reaching, and climbing stairs, with or without accommodation.

+ Comfort working in a plant producing radioactive materials and adhering to strict safety procedures.

Additional

Skills & Qualifications

+ Associate Degree or completion of an equivalent certification program from a technical or vocational school, or equivalent relevant years of experience in a related field.

+ Scientific background is preferred and beneficial for understanding pharmaceutical processes.

+ Experience in pharmaceutical production, packaging, or other cGMP processing environments.

+ Ability to work effectively in a team-based environment and provide leadership on the production floor.

+ Interest in career growth within an advanced developmental path where many supervisors have progressed from technician roles.

Work Environment

This role operates within a sterile, cleanroom production environment with defined gowning requirements.

The position follows a rotating 10-hour schedule, including:

+ Week 1 (Sunday-Wednesday, 5:00 p.m.

- 3:30 a.m.)

+ Week 2 (Monday-Wednesday, 5:00 p.m.

- 3:30 a.m.)

+ Week 3 (Saturday-Tuesday, 5:00 p.m.

- 3:30 a.m.)

The facility produces radioactive materials, and all employees participate in comprehensive safety programs designed to minimize potential and actual exposure levels. Team…