Manufacturing Systems Engineer

2 days ago

Albany, New York, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Manufacturing Systems Engineer to join our team at BioSpace, Inc. in New Albany, Ohio. As a key member of our operations team, you will be responsible for providing technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications.

Key Responsibilities
  • 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.
  • 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 and 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, troubleshoot, and repair equipment/system failures.
  • Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&IDs.
  • Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
Requirements
  • Bachelor's degree or equivalent in a relevant field.
  • Or Associate's degree and 4 years of Technical Engineering experience.
  • Or High school diploma/GED and 6 years of Technical Engineering experience.
  • Preferred qualifications include 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 HMIs, 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, PowerPoint.
What We Offer

We offer a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

Stock-based long-term incentives.

Award-winning time-off plans and bi-annual company-wide shutdowns.

Flexible work models, including remote work arrangements, where possible.

We are an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

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