Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products. Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.
Position Brand Description:
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. 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 Maintenance (FBO) Engineer will also support and execute projects that improve the efficiency of the maintenance programs. When excursions are reported the 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.
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
1. 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.
2. Act as an FBO/Maintenance engineering SME, as applicable, for specific equipment types (ex. manufacturing, HVAC, lab, electrical, etc.).
3. Manage the acquisition, decommissioning, relocation, or modification of equipment.
4. Conduct assessments of systems to develop the maintenance plans and determine spare parts stocking strategy.
5. Complete the Maintenance Package Development process including location/asset identification, job plans, preventative maintenance frequency, and calibration data sheets.
6. 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.
7. Investigate deviations and/or complete FUME-related action records.
8. Assist Maintenance Scheduler/Planners in coordinating shutdowns when necessary for project work.
9. Work in the Document Management System to
a. Create documents related to acquisitions, decommissions, etc. for review and approval.
b. Develop or update Standard Operating Procedures (SOPs) and forms
c. Complete periodic reviews of maintenance and departmental procedures.
10. Employ the Computerized Maintenance Management System (Maximo) to:
a. Create, revise, and ensure approval of job plans to support equipment additions and changes as it may relate to engineering projects, maintenance requests, or continuous improvement.
b. Enter new or revise existing spare parts data.
Basic Requirements:
1. Minimum of 0 years to 5 years experience working in a cGMP environment in a facilities or engineering capacity.
2. Project management, problem solving and team building skills required.
3. Excellent attention to detail.
4. Strong technical writing and communication skills.
5. Strong organizational skills with the ability to prioritize and manage multiple improvement projects.
6. Self-motivated with the ability to work both independently and with teams.
7. Fast learner on new software systems.
8. Must demonstrate leadership qualities.
Additional Preferences:
1. Working knowledge of MS Office suite and Maximo a plus.
2. Experience in Plant/Facilities, Maintenance, or Engineering in the pharmaceutical/biotechnology sector.
Education Requirements:
1. Bachelor of Science in Engineering (Chemical, Mechanical or Civil/Structural and preferred) or equivalent work experience.
Other Information:
Minimal Travel and Lifting.
This role is exempt and the anticipated compensation for this role is $72,000 - $116,000.
This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.
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 benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.
Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.
