What are the responsibilities and job description for the Sr. Manufacturing Technician position at Astrix?
Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Maintenance Technician. We are seeking a dynamic individual who is eager to contribute their expertise and drive their mission forward.
Shift:
Training: Day shift (2-6 weeks)
After Training: Night Shift
Location: Thousand Oaks, CA
Key Responsibilities:
LIDNP
Shift:
Training: Day shift (2-6 weeks)
After Training: Night Shift
Location: Thousand Oaks, CA
Key Responsibilities:
- Maintain and repair all production mechanical equipment at the Amgen Fill/Finish facility.
- Support the maintenance, operation, and repair of all systems, subsystems, and equipment.
- Provide support to engineering and operations in the design, installation, testing, operation, and maintenance of manufacturing equipment.
- Ensure all assigned equipment and subsystems are maintained per federal, state, local, and Amgen regulations, procedures, and policies.
- Maintain equipment areas in a constant state of inspection readiness.
- Identify training deficiencies and provide recommendations/training as needed.
- Continuously evaluate and improve maintenance practices and documentation.
- Troubleshoot electrical, pneumatic, and mechanical equipment.
- Complete preventive maintenance and associated paperwork in compliance with cGMP documentation requirements.
- Coordinate contractors for repairs, modifications, and installations.
- Work with Manufacturing, Engineering, and Quality teams on system installations or modifications.
- Attend required cGMP and safety training and maintain assigned qualifications.
- Associate’s degree and 4 years of experience, or High School diploma/GED and 6 years of experience.
- At least 10 years of experience working with process or utility equipment, preferably in a GMP-regulated pharmaceutical environment.
- Strong technical skills in electrical, mechanical, and electromechanical systems with knowledge of HVAC systems being beneficial.
- Familiarity with work order systems preferred.
- Thorough working knowledge of pharmaceutical packaging equipment, pumps, valves, mechanical seals, motors, and proper lubrication.
- Strong documentation and attention to detail skills, with full knowledge of cGMP and predictive maintenance techniques.
- Ability to create, read, interpret, and revise engineering documents (e.g., P&IDs, SOPs).
- Strong writing skills for preparing technical reports and documentation.
- Ability to work independently with minimal supervision.
- Familiarity with machine shop equipment (CNC machines, lathe) is a plus.
- Ability to work safely with hazardous chemicals, high-pressure liquids/gases, steam, electrical systems, and moving machinery.
- Proficiency in using Computerized Maintenance Management Systems (CMMS).
- Strong communication and interpersonal skills.
LIDNP
