Instrumentation​/Calibration Maintenance Engineer

This position will support multiple site-wide Engineering and Maintenance groups in the acquisition (or decommission) of equipment including the Manufacturing, Utility and Lab areas with a special focus on instrumentation and calibrations. The Engineer will perform assessments on systems and consult with SMEs to create robust maintenance plans to extend the life of equipment in our Facilities. The Instrument Maintenance (FBO) Engineer will also support and execute projects that improve the efficiency of the maintenance programs.

When excursions are reported the Instrument Maintenance Engineer will lead or assist with the investigation of the event to determine both root cause and corrective/preventative actions. This position will assist or lead in documenting, organizing and coordinating activities such as Computerized Maintenance Management System (CMMS) support, deviation investigations, reliability, asset disposition, lean practices, process optimization, technical investigations, and change controls.

• 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.

• 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.

• 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.

This is an exempt, salaried role with an anticipated compensation range of $72,000 - $116,000.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability coverage.

The position does not require travel; it may require on-call availability and could involve shift work. Hybrid work flexibility is available based on business needs; relocation assistance is not provided.

Celltrion is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.