Celltrion Inc · 17 hours ago
Instrumentation/ Calibration Maintenance Engineer
Branchburg, NJ, US
Full-time
Hybrid
Entry Level
$72K/yr - $116K/yr
1+ years expCelltrion Inc is a company focused on engineering and maintenance solutions. They are seeking an Instrumentation/Calibration Maintenance Engineer to support site-wide engineering projects, manage equipment maintenance, and lead investigations into system deviations.
Health CarePharmaceutical
Responsibilities
Support site engineering projects and process teams by representing FBO and the Maintenance Technicians, ensuring that records related to the Maintenance Package are created or updated
Serve as an Instrument Maintenance engineering SME for specific equipment types (ex. manufacturing, HVAC, lab, electrical, etc.) with a special focus on instrumentation, lab equipment, and calibration
Responsible for the calibration certificate review of calibration standards, and identification and replacement of Calibration standards based on instrumentation and process requirements
Manage the acquisition, decommissioning, relocation, or modification of equipment
Conduct assessments of systems to develop the maintenance plans and determine spare parts stocking strategy
Complete the Maintenance Package Development process including location/asset identification, job plans, preventative maintenance frequency, and calibration data sheets
Utilize the change management system to assess & document the impact to the maintenance package for changes to GMP equipment and systems. Complete the associated change control actions
Investigate deviations and/or complete FUME-related action records
Assist Maintenance Scheduler/Planners in coordinating shutdowns when necessary for project work
Work in the Document Management System to create documents related to acquisitions, decommissions, etc. for review and approval
Develop or update Standard Operating Procedures (SOPs) and forms
Complete periodic reviews of maintenance and departmental procedures
Employ the Computerized Maintenance Management System (Maximo) to create, revise, and ensure approval of job plans and calibration data sheets to support equipment additions and changes as it may relate to engineering projects, maintenance requests, or continuous improvement
Enter new or revise existing spare parts data
Qualification
Required
Bachelor of Science in Engineering (Chemical, Mechanical, or Electrical) or equivalent work experience
Minimum of 1 year of experience working in a cGMP environment in a facilities or engineering capacity
Ability to lift 50 pounds or more
Understanding of statistical processes
Project management, problem solving and team building skills required
Excellent attention to detail
Strong technical writing and communication skills
Strong organizational skills with the ability to prioritize and manage multiple improvement projects
Self-motivated with the ability to work both independently and with teams
Fast learner on new software systems
Must demonstrate leadership qualities
Preferred
Working knowledge of MS Office suite and Maximo a plus
Hands on Calibration experience
Experience in Plant/Facilities, Maintenance, or Engineering in the pharmaceutical/biotechnology sector
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability coverage
Company
Celltrion Inc
Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase