Duration: 4+Years
Location: Thousand Oaks, CA
Day shift- 630 am - 3 pm for first 3-6 months then will transition to 2nd shift 6 pm- 6 am (a few days on few days off)
Associate Mfg Systems Engineer:
Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.
The original work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm) and then move to a second shift schedule. As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgen’s 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.
Responsibilities:
• Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies. Investigate complex issues or problems through the mentorship of experienced staff.
• Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
• Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
• Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID’s.
• Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
Basic Qualifications:
• High school diploma / GED and 6 years of Technical Engineering experience OR
• Associate’s degree and 4 years of Technical Engineering experience OR
• Bachelor’s degree
Preferred Qualifications:
• Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
• Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
• SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
• Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
• Experience with automation system hardware and software support, including installation
• Excellent organizational, project management, problem solving and technical writing capability
• Strong communication: verbal / written, collaboration, influencing and facilitation
• MS Office: Word, Excel, Power Point
...will not sponsor OR transfer H1B - looking for W2 candidates only No 3rd party Overview: We are seeking a Senior Full Stack Developer to design, build, and maintain scalable web applications. This role requires strong expertise across front-end and back-end...
...Proactively follow up with leads from phone, web, and social media inquiries to convert them into consultations or treatments Schedule, confirm, and manage appointments using booking software Handle client check-outs, process payments, and manage accurate client...
...Are you ready to embark on a thrilling adventure in the world of covert surveillance? Team 360 Staffing, on behalf of Meridian Investigative Group , is seeking a Covert Surveillance Investigator to join their dynamic Investigative Team. Your mission, should you choose...
...Dental Assistant Oral Surgery (Surgical Assistant) Location: West Chester + Kennett Square + Wayne, PA (travel required to all locations as needed) Schedule: Full-time | MondayFriday Website: Who We Are Chester County Oral Surgery & Dental Implants...
...applicants must be a current US resident. ESI is now hiring an RN Clinical Care Coordinator in the Stuart, FL area.... ...Coordinator who is responsible for completing initial and ongoing assessments to identify the physical, psychosocial and environmental needs...